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GOOD   

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AFTERNOON EVERYONE. MY NAME IS 

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DR. ALTAN-BONNET, AND 

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INVESTIGATOR IN HIV, AND 

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COCHAIR OF THE CVOID-19 

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SCIENTIFIC INTEREST GROUP. IT 

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IS A PLEASURE TO HAVE JEANNE 

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MARRAZZO. 

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DR. MARRAZZO WAS RECENTLY 

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APPOINTED AS THE DIRECTOR OF 

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NIAID, PREVIOUSLY THE DIRECTOR 

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OF THE UNIVERSITY OF ALABAMA 

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SCHOOL OF INFECTIOUS DISEASES 

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AND SHE EARNED HER BACHELORS 

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DEGREE ANALOGY FROM HARVARD 

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UNIVERSITY, HER MD FROM THOMAS 

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JEFFERSON UNIVERSITY AND A 

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MASTERS IN PUBLIC HEALTH AND 

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EPIDEMIOLOGY FROM UNIVERSITY IN 

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WASHINGTON AND COMPLETED 

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RESIDENCY AND CHIEF RESIDENCY 

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IN INTERNAL MEDICINE AT YALE 

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NEW HAVEN HOSPITAL AND DR. 

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MARRAZZO IS MADE FOR 

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GROUNDBREAKING CONTRIBUTORS TO 

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THE FIELD OF SEX WITH AS MANY 

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DISEASES AND RESEARCHERS PLAYED 

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A CRITICAL ROLE IN THE FEMALE 

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MICROBIOME, AND HIV FEMALE 

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TRANSMISSION AND APPLICATION 

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AND IS THE AUTHOR OF OVER 250 

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PUBLICATIONS AND HAS RECEIVED 

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NUMEROUS AWARDS AND HONORS 

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INCLUDING RECENTLY THE AMERICAN 

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SEXUAL TRANSMITTED DISEASES 

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ASSOCIATION'S THE THING WAS 

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CAREER AWARD AND MEMBER OF THE 

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COLLEGE OF AMERICAN PHYSICIANS 

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AND-- CHAIR OF THE AMERICAN 

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BOARD OF INTERNAL MEDICINE 

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COUNCIL. AND THE BOARD OF 

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INTERNAL MEDICINE COUNCIL 

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INFECTIOUS DISEASES BOARD. 

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THANK YOU FOR BEING HERE TODAY 

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AND WE LOOK FORWARD TO YOUR 

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TALK ON THE LATEST NIH 

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INITIATIVE REGARDING LONG COVID 

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DIAGNOSIS AND INTERVENTIONS. 

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>> DR. MARRAZZO:CAN YOU
ALL SEE 

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THAT?

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>> YES WE CAN SEE IT. 

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>> DR. MARRAZZO: ALL RIGHT
GOOD 

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LET ME MINIMIZE THE OTHER 

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PICTURES HERE. FIRST OF ALL IT 

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IS A FANTASTIC OPPORTUNITY TO 

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SPEAK WITH YOU ALL TODAY AND 

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I'M DELIGHTED TO BE HERE, AND 

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ACTUALLY JUST CELEBRATING MY 

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ONE YEAR ANNIVERSARY AS OF A 

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COUPLE OF DAYS AGO. WHICH IS A 

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LITTLE HARD FOR ME TO BELIEVE. 

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BUT IT'S BEEN A GREAT YEAR, 

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LOOKING FORWARD TO THE ONE 

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AHEAD.

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SO IT'S ALSO FUN TO TALK TO 

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THIS GROUP RIGHT NOW ABOUT WHAT 

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IS HAPPENING WITH A NEW 

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INITIATIVE, BUILDING ON THE 

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EXISTING RECOVER FRAMEWORK.

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AND GOING OVER WHAT IS FOR YOU 

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FAMILIAR TERRAIN IN TERMS OF 

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WHERE WE ARE AT WITH LONG 

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COVID, NOT JUST TRYING TO 

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UNDERSTAND THE EPIDEMIOLOGY BUT 

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THE PATHOBIOLOGY, AND WHAT WE 

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ARE THINKING ABOUT IN TERMS OF 

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TREATMENT BUT MAYBE PROVIDE A 

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LITTLE PERSPECTIVE BASED ON 

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WHAT I HEARD, AND WHAT WAS 

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PRESENTED DURING THE INAUGURAL 

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WORKSHOP THAT JUST ENDED AS 

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SOME OF YOU KNOW YESTERDAY. 2 

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1/2 DAY WORKSHOP TO BRING 

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TOGETHER AS MANY PEOPLE AS WE 

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COULD, INCLUDING PATIENTS, 

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ADVOCATES, COMMUNITY MEMBERS, 

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RESEARCHERS, RECOVERY TEAMS, 

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HLIBI, NIAID AND CATS, THINKING 

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ABOUT THE FUTURE OF HOW WE 

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SHOULD DO CLINICAL TRIALS IN 

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LONG COVID AS I KNOW YOU KNOW 

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IT IS AN INCREDIBLY COMPLICATED 

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AREA. 

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AND IT IS AN AREA OF REALLY 

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URGENT NEED. SO I APOLOGIZE IF 

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SOME OF THE EARLY SLIDES ARE 

97
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LITTLE OBVIOUS TO ANY OF YOU 

98
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WHO KNOW A LOT ABOUT LONG COVID 

99
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I DO NOT CONSIDER MYSELF A LONG 

100
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COVID EXPERT AND I HAVE TREATED 

101
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LONG COVID, AND NOT CURRENTLY 

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DOING RESEARCH IN LONG COVID 

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BUT I WANTED TO PUT IN 

104
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PERSPECTIVE WHAT I THINK ARE 

105
00:04:05,731 --> 00:04:07,032
SOME OF THE STATE OF YOUR 

106
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THOUGHTS ABOUT WHERE WE ARE AND 

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MOST IMPORTANTLY FOR THIS ONE, 

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FOR THIS TALK THINKING ABOUT 

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HOW THAT GETS US TO THINKING 

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CREATIVELY AND URGENTLY ABOUT 

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CLINICAL TRIALS. 

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SO LET'S GO AHEAD AND GO 

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FORWARD. 

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THERE WE GO. ASSUMING YOU CAN 

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SEE ALL OF THAT. 

116
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SO, SOMEBODY AT THE MEETING 

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SAID, THEY HAD A DOLLAR FOR 

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EVERY TIME THEY HAD SEEN THIS 

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SLIDE THEY WOULD BE A RICH 

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PERSON BUT IT DOES MAKE SOME 

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REALLY NICE POINTS. AND 

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UNFORTUNATELY, JUST TODAY, AN 

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ARTICLE CAME OUT I BELIEVE FROM 

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-- TALKING ABOUT THE 

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PATHOPHYSIOLOGY, THAT HAS SOME 

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FANTASTIC GRAPHICS AND IF I HAD 

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 TIME, I WOULD'VE UPDATED THE 

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SLIDE. 

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BOTH IN THE EXPERIENCE OF LONG 

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COVID, STUDYING AND TREATING 

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LONG COVID, IS A WIDE ARRAY OF 

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CLINICAL SYNDROMES AND SYMPTOMS 

133
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THAT WE SEE. ONE OF THE 

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IMPLICATIONS HERE IS THAT WE 

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REALLY, REALLY NEED A 

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MULTIDISCIPLINARY APPROACH. 

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RIGHT?

138
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WE STARTED OFF AND I THINK 

139
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EARLY IN THE PANDEMIC, THE 

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EARLIEST INDICATIONS... AT 

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LEAST FROM MY PERSPECTIVE IT 

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WAS ON MANY, MANY PATIENTS WITH 

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COVID WHEN I WAS IN BIRMINGHAM. 

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MOST OF THE INDICATIONS WERE 

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CARDIOPULMONARY, PEOPLE HAD 

146
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PERSISTENT PROBLEM WITH 

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EXERCISE- INDUCED -- CARDIAC 

148
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PUBLICATIONS AND HAVING 

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PROSTHETIC DYSREGULATION OF THE 

150
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BLOOD PRESSURE AND HEART RATE. 

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SO WE HAVE REALLY EXPANDED THE 

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DEFINITION OF WHAT ENCOMPASSES 

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THE SYNDROME IN THE WORLD OF 

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LONG COVID CONSIDERABLY SINCE 

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THEN. 

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THIS SLIDE MAKES THE POINT THAT 

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THE LUNGS, HEART, PANCREAS, THE 

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IMMUNE SYSTEM, GASTROINTESTINAL 

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SYSTEM, SPLEEN, LIVER AND 

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NEUROLOGICAL SYSTEMS ARE THE 

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MAJOR ELEMENTS IN TERMS THE 

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AREAS AFFECTED. 

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IN PINK YOU HAVE NOT ONLY THE 

164
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SYMPTOMS PEOPLE REPORT; IN BLUE 

165
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YOU HAVE THE APOLOGY THAT AS OF 

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2023 HAD BEEN DOCUMENTED, USING 

167
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REALLY INCREASINGLY 

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SOPHISTICATED APPROACHES TO 

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CHARACTERIZING TISSUES. 

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FOR EXAMPLE, WE KNOW THAT THE 

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PANCREAS CAN BE NONNORMAL IN 

172
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LONG COVID; AND THAT IS ONE OF 

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THE REASONS THAT PEOPLE HAVE AN 

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ELEVATED RISK OF DIABETES. 

175
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WE KNOW THAT THERE ARE 

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EXTENSIVE DISORDERS IN THE 

177
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BLOOD VESSELS INCLUDING MICRO 

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CLOTS, INCLUDING ENDOTHELIAL 

179
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DYSFUNCTION AND MICRO 

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CUAGOLOPATHY AND DEVAIN 

181
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THROMBOSIS. 

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EARLY ON FOR THE FIRST COUPLE 

183
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OF YEARS PEOPLE COMPLAINING OF 

184
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GUT DISTURBANCES, ABDOMINAL 

185
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PAIN AND NAUSEA, PARTICULAR 

186
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SOMETIMES DIARRHEA, BUT THE 

187
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DISORDERS WERE DISMISSED 

188
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BECAUSE PEOPLE WERE, WELL, WHY 

189
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WOULD THE GUT BE AFFECTED?

190
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WE NOW KNOW THAT WE CAN FIND 

191
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THE VIRUS IN THE GUT.  CARDIAC 

192
00:07:22,727 --> 00:07:24,029
IMPAIRMENT WE KNEW ABOUT EARLY 

193
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ON BECAUSE WE ALL-- MANY OF US 

194
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ARE PEOPLE PRESENTING WITH 

195
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MYOCARDITIS, OUTSIDE OF THE ONE 

196
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ASSOCIATED WITH RMNA REGULATION 

197
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WHICH WAS REAL AND THE BRAIN 

198
00:07:43,715 --> 00:07:44,316
FOG OR COGNITIVE IMPAIRMENT, 

199
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ONE OF THE COGNITIVE SYMPTOMS. 

200
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BUT A LOT OF OTHER THINGS 

201
00:07:47,853 --> 00:07:51,857
INCLUDING DISORDERS OF SLEEP, 

202
00:07:51,857 --> 00:07:52,390
AND FATIGUE, AND CARDINAL 

203
00:07:52,390 --> 00:07:53,024
SYMPTOMS AS WELL; WHEN YOU LOOK 

204
00:07:53,024 --> 00:07:59,664
IN THE BRAIN YOU DO FIND NEURON 

205
00:07:59,664 --> 00:08:00,298
FORMATION. YOU CAN SEE REDUCED 

206
00:08:00,298 --> 00:08:00,932
BLOOD FLOW, POSSIBLY RELATED TO 

207
00:08:00,932 --> 00:08:05,971
SOME OF THE THROMBO PATHOLOGY I 

208
00:08:05,971 --> 00:08:12,110
TALKED ABOUT THE BELOW. AND-- 

209
00:08:12,110 --> 00:08:15,981
PROPENSITY FOR CLOTS AND -- SO 

210
00:08:15,981 --> 00:08:16,548
THERE'S A TON GOING ON HERE 

211
00:08:16,548 --> 00:08:22,888
BOTH PATHOLOGICALLY AND 

212
00:08:22,888 --> 00:08:25,290
SYNDROMICALLY  TAKING A STEP 

213
00:08:25,290 --> 00:08:32,297
BACK ABOUT HOW TO DESIGN 

214
00:08:32,297 --> 00:08:32,931
TRIALS, YOU CAN APPRECIATE THE 

215
00:08:32,931 --> 00:08:33,498
COMPLEXITY ABOUT TRYING TO 

216
00:08:33,498 --> 00:08:34,099
DEVELOP THE PRIMARY ENDPOINT, 

217
00:08:34,099 --> 00:08:34,733
OR SEND SECONDARY ENDPOINTS FOR 

218
00:08:34,733 --> 00:08:35,367
ANY CLINICAL TRIALS. 

219
00:08:35,367 --> 00:08:36,735
WHY IS THIS HAPPENING? WE STILL 

220
00:08:36,735 --> 00:08:40,372
DO NOT KNOW.  THE NEXT SLIDE 

221
00:08:40,372 --> 00:08:41,006
I'M GOING TO SHOW YOU IS GOING 

222
00:08:41,006 --> 00:08:51,549
TO TALK A LITTLE BIT MORE ABOUT 

223
00:08:52,450 --> 00:08:53,018
THE EPIDEMIOLOGY ELEGY AND HOW 

224
00:08:53,018 --> 00:08:58,556
PREVALENT THIS IS -- AL-ALY HAS 

225
00:08:58,556 --> 00:09:00,158
BEEN A REAL CHAMPION FOR 

226
00:09:00,158 --> 00:09:00,725
PATIENT SUFFERING FROM THE 

227
00:09:00,725 --> 00:09:02,794
DISORDER. 

228
00:09:02,794 --> 00:09:03,328
THIS IS A NICE DIAGRAM THAT 

229
00:09:03,328 --> 00:09:05,664
GIVES YOU A SENSE OF THE ART 

230
00:09:05,664 --> 00:09:09,401
WOULD SAY COUNTERVAILING, NOT 

231
00:09:09,401 --> 00:09:12,370
REALLY CONTRADICTORY MECHANISM. 

232
00:09:12,370 --> 00:09:15,373
 IT MAY TURN OUT THAT THERE ARE 

233
00:09:15,373 --> 00:09:15,974
MORE THAN ONE-- THERE IS MORE 

234
00:09:15,974 --> 00:09:16,541
THAN ONE MECHANISM AT PLAY 

235
00:09:16,541 --> 00:09:21,012
HERE. 

236
00:09:21,012 --> 00:09:22,380
PERSISTENT VIRUS HAS BEEN A 

237
00:09:22,380 --> 00:09:25,216
MAJOR CONCERN, BUT WE STILL DO 

238
00:09:25,216 --> 00:09:26,918
NOT KNOW IF IT IS A VIRAL 

239
00:09:26,918 --> 00:09:30,588
ANTIGEN. IS IT A SPIKE PROTEIN? 

240
00:09:30,588 --> 00:09:34,225
IS A VIRAL RNA? IS THERE ACTIVE 

241
00:09:34,225 --> 00:09:34,826
REPLICATION OF THIS VIRUS? WE 

242
00:09:34,826 --> 00:09:36,962
DO NOT KNOW.

243
00:09:36,962 --> 00:09:39,497
WE DO KNOW THAT THE 

244
00:09:39,497 --> 00:09:40,131
PERTURBATIONS THAT WHATEVER IS 

245
00:09:40,131 --> 00:09:41,199
GOING ON WITH THIS HYPOTHESIS 

246
00:09:41,199 --> 00:09:41,766
OF THE PERSISTENT VIRUSES 

247
00:09:41,766 --> 00:09:44,636
PROPOSED, LEADS TO SOME OF THE 

248
00:09:44,636 --> 00:09:47,305
THINGS THAT ARE SHOWN IN YELLOW 

249
00:09:47,305 --> 00:09:57,816
THERE. AND BESIDE LYMPHOCITE 

250
00:09:59,951 --> 00:10:03,922
ACTIVATION. EXHAUSTION, 

251
00:10:03,922 --> 00:10:04,522
ANTIBODY SECRETION... AND ON 

252
00:10:04,522 --> 00:10:08,259
THE OTHER SIDE SEVERAL LABS 

253
00:10:08,259 --> 00:10:09,527
HAVE PROPOSED A COMPONENT OF 

254
00:10:09,527 --> 00:10:10,895
AUTOIMMUNITY THAT HAS 

255
00:10:10,895 --> 00:10:13,398
ESSENTIALLY ENGENDERED 

256
00:10:13,398 --> 00:10:14,032
PERSISTENT ORDER REACTION IN T 

257
00:10:14,032 --> 00:10:20,205
CELLS.  SOME OF THAT HAS BEEN 

258
00:10:20,205 --> 00:10:20,739
LINKED TO THIS CONDITION, 

259
00:10:20,739 --> 00:10:21,906
REACTIVATING PARTICULARLY 

260
00:10:21,906 --> 00:10:29,681
HERPES VIRUSES LIKE ST VIRUS, 

261
00:10:29,681 --> 00:10:30,315
WHICH CONTRIBUTE TO ACTIVATION 

262
00:10:30,315 --> 00:10:31,916
OF T CELLS, PARTICULARLY HERPES 

263
00:10:31,916 --> 00:10:37,255
SIMPLEX VIRUS. BUT EDD HAS BEEN 

264
00:10:37,255 --> 00:10:42,060
THE MOST CLOSELY IMPLICATED. 

265
00:10:42,060 --> 00:10:42,594
THE BOTTOM LINE THAT ALL OF 

266
00:10:42,594 --> 00:10:44,095
THESE THINGS END UP LEADING TO 

267
00:10:44,095 --> 00:10:44,929
SYSTEMIC INFLAMMATION, TISSUE 

268
00:10:44,929 --> 00:10:47,665
DAMAGE AND TISSUE DYSFUNCTION 

269
00:10:47,665 --> 00:10:48,266
THROUGH THE PROCESSES LINK OR 

270
00:10:48,266 --> 00:10:58,176
NOTED IN THOSE PINK BOXES. I 

271
00:10:58,176 --> 00:10:58,643
MENTIONED THRHOMBOID 

272
00:10:58,643 --> 00:11:04,382
INFORMATION AND, PITUITARY 

273
00:11:04,382 --> 00:11:04,916
INFLAMMATION, MICRO GLIAL 

274
00:11:04,916 --> 00:11:05,517
INFLAMMATION INTERESTING TALK 

275
00:11:05,517 --> 00:11:07,452
IF YOU DO NOT GET A CHANCE TO 

276
00:11:07,452 --> 00:11:08,053
COME TO THE WORKSHOP. IT WAS 

277
00:11:08,053 --> 00:11:08,686
RECORDED AND WILL BE RELEASING 

278
00:11:08,686 --> 00:11:17,228
BOTH A BLOG AND MANUSCRIPT 

279
00:11:17,228 --> 00:11:17,762
SCIENTIFIC REPORT REALLY 

280
00:11:17,762 --> 00:11:18,363
FASCINATING DATA ON MICROGLIA 

281
00:11:18,363 --> 00:11:18,997
ACTIVATION THAT I HAD NOT QUITE 

282
00:11:18,997 --> 00:11:23,535
APPRECIATED. 

283
00:11:23,535 --> 00:11:26,571
MITOCHONDRIAL DYSFUNCTION-- YOU 

284
00:11:26,571 --> 00:11:28,907
COULD EXPLAIN THE MICRO VIRUS 

285
00:11:28,907 --> 00:11:31,276
DYSFUNCTION AND TRANSLOCATION. 

286
00:11:31,276 --> 00:11:34,345
THIS IS A COMPLEX 

287
00:11:34,345 --> 00:11:34,846
MULTISYSTEMIC, POSSIBLY 

288
00:11:34,846 --> 00:11:37,015
MULTIFACTORIAL CONDITION THAT 

289
00:11:37,015 --> 00:11:37,549
WE ARE REALLY IN NEED OF 

290
00:11:37,549 --> 00:11:39,184
LEARNING A LOT MORE ABOUT. 

291
00:11:39,184 --> 00:11:41,319
IT IS REALLY PREVALENT. AND I 

292
00:11:41,319 --> 00:11:44,189
WILL SAY THAT I THINK THE 

293
00:11:44,189 --> 00:11:49,260
NUMBERS THAT I AM GOING TO SHOW 

294
00:11:49,260 --> 00:11:51,296
HERE ARE PROBABLY A GROSS 

295
00:11:51,296 --> 00:11:52,564
UNDERESTIMATE PREVIOUS UNDER 

296
00:11:52,564 --> 00:11:58,770
PREVIOUS NATURE MEDICINE 

297
00:11:58,770 --> 00:11:59,404
REVIEW. HE THINKS AND WROTE THE 

298
00:11:59,404 --> 00:11:59,971
CUMULATIVE INCIDENCE MAY BE 

299
00:11:59,971 --> 00:12:00,572
ABOUT 400 MILLION CASES, WITH 

300
00:12:00,572 --> 00:12:01,639
THE NATIONAL ECONOMIC IMPACT OF 

301
00:12:01,639 --> 00:12:07,846
ABOUT A TRILLION, 1% OF THE 

302
00:12:07,846 --> 00:12:08,480
GLOBAL A COMMONALITY LISTENING 

303
00:12:08,480 --> 00:12:09,214
TO SOME OF PEOPLE LIVING WITH 

304
00:12:09,214 --> 00:12:11,349
LONG COVID AT THE MEETING OVER 

305
00:12:11,349 --> 00:12:13,251
THE LAST DAYS, I THINK THAT IS 

306
00:12:13,251 --> 00:12:20,792
PROBABLY AN UNDERESTIMATE. WHEN 

307
00:12:20,792 --> 00:12:21,326
YOU THINK ABOUT LOST LIFE 

308
00:12:21,326 --> 00:12:24,162
YEARS, PARTICULAR TIME FOR 

309
00:12:24,162 --> 00:12:24,796
CAREGIVERS, EFFECT ON FAMILIES 

310
00:12:24,796 --> 00:12:25,697
WHEN PARENTS AND CHILDREN ARE 

311
00:12:25,697 --> 00:12:27,999
AFFECTED. IT HAS BEEN QUITE 

312
00:12:27,999 --> 00:12:28,600
PROFOUND. I THINK IT IS WORTH 

313
00:12:28,600 --> 00:12:30,502
KEEPING THOSE IN MIND. 

314
00:12:30,502 --> 00:12:32,604
BUT LET'S LOOK AT THE MORE 

315
00:12:32,604 --> 00:12:34,372
FORMAL DATA HERE. A PAPER 

316
00:12:34,372 --> 00:12:37,342
PUBLISHED IN JANA IN OCTOBER 

317
00:12:37,342 --> 00:12:47,452
2022. 

318
00:12:48,119 --> 00:12:48,686
REMEMBER THIS IS PRETTY EARLY 

319
00:12:48,686 --> 00:12:49,320
IN THE PANDEMIC WHEN YOU THINK 

320
00:12:49,320 --> 00:12:51,890
ABOUT THIS. THIS IS PROBABLY 

321
00:12:51,890 --> 00:12:53,124
MOST REFERS TO PEOPLE WHO WERE 

322
00:12:53,124 --> 00:12:53,758
AFFECTED IN THE FIRST WAVE AND 

323
00:12:53,758 --> 00:12:54,359
PERHAPS IN THE DELTA WAVE BUT 

324
00:12:54,359 --> 00:12:55,827
NOT VERY FAR. NOT WHERE WE ARE 

325
00:12:55,827 --> 00:12:59,597
AT TODAY. 

326
00:12:59,597 --> 00:13:01,766
THIS DOES NOT REFLECT A LOT OF 

327
00:13:01,766 --> 00:13:04,435
REINFECTIONS; DOES NOT REFLECT 

328
00:13:04,435 --> 00:13:06,738
INFECTIONS WITH SUBSEQUENT 

329
00:13:06,738 --> 00:13:07,338
VARIANTS. AND THAT IS ONE OF 

330
00:13:07,338 --> 00:13:07,906
THE HUGE CHALLENGES WE ARE 

331
00:13:07,906 --> 00:13:08,940
GOING TO TALK ABOUT IN STAGING 

332
00:13:08,940 --> 00:13:10,675
TRIALS FOR LONG COVID. 

333
00:13:10,675 --> 00:13:11,576
SO WHEN YOU LOOK AT THE 

334
00:13:11,576 --> 00:13:14,979
PROPORTION WITH LONG COVID, OF 

335
00:13:14,979 --> 00:13:19,050
PEOPLE ACROSS THE GLOBE, THIS 

336
00:13:19,050 --> 00:13:19,684
IS THE GLOBAL BURDEN OF DISEASE 

337
00:13:19,684 --> 00:13:23,188
FOR THE LONG COVID COLLABORATOR 

338
00:13:23,188 --> 00:13:25,823
TEAM. 

339
00:13:25,823 --> 00:13:26,424
THE PROBLEMS OF COURSE DEPENDS 

340
00:13:26,424 --> 00:13:28,927
ON HOW YOU DEFINE IT.  WE ARE 

341
00:13:28,927 --> 00:13:30,461
GOING TO TALK ABOUT THE 

342
00:13:30,461 --> 00:13:30,962
DEFINITION, BECAUSE THE 

343
00:13:30,962 --> 00:13:31,362
DEFINITION IS NOT 

344
00:13:31,362 --> 00:13:34,065
STRAIGHTFORWARD EITHER. 

345
00:13:34,065 --> 00:13:41,039
NOTHING THAT THEY USED  I WOULD 

346
00:13:41,039 --> 00:13:41,539
SAY MOST LIBERALLY WAS 

347
00:13:41,539 --> 00:13:44,075
SOMETHING CALLED THE SYMPTOM 

348
00:13:44,075 --> 00:13:44,709
CLUSTER. AND WILL SHOW YOU WHAT 

349
00:13:44,709 --> 00:13:45,310
THAT MEANS IN THE SLIDE AFTER 

350
00:13:45,310 --> 00:13:46,211
THE NEXT ONE. 

351
00:13:46,211 --> 00:13:51,716
BASICALLY IT MEANS A GROUP OF 

352
00:13:51,716 --> 00:13:54,152
CLUSTERS OF SYMPTOMS, OR A 

353
00:13:54,152 --> 00:13:54,719
CLUSTER OF SYMPTOMS LIKE I 

354
00:13:54,719 --> 00:13:56,621
SHOWED YOU BEFORE, G.I. 

355
00:13:56,621 --> 00:13:57,722
SYMPTOMS, NEUROLOGICAL 

356
00:13:57,722 --> 00:14:00,825
SYMPTOMS, ETC.

357
00:14:00,825 --> 00:14:03,228
PROBABLY THAT WAS THE MOST 

358
00:14:03,228 --> 00:14:03,828
COMMON MANIFESTATION BUT WHEN 

359
00:14:03,828 --> 00:14:04,462
YOU LOOK INDIVIDUALLY SYMPTOMS 

360
00:14:04,462 --> 00:14:06,698
ARE NOTED THERE, YOU SEE PRETTY 

361
00:14:06,698 --> 00:14:10,635
HIGH PREVALENCES. 

362
00:14:10,635 --> 00:14:11,236
THE OTHER THING YOU SEE IN THE 

363
00:14:11,236 --> 00:14:11,869
SLIDE IS THAT IT TENDS TO HAVE 

364
00:14:11,869 --> 00:14:22,380
A PREDILECTION FOR WOMEN.  WE 

365
00:14:23,414 --> 00:14:23,982
KNOW THAT MANY AUTOIMMUNE-- IN 

366
00:14:23,982 --> 00:14:24,582
PARTICULAR PHENOMENA THAT DO 

367
00:14:24,582 --> 00:14:25,149
AFFECT WOMEN MORE, BUT NOT 

368
00:14:25,149 --> 00:14:25,817
SUBSTANTIAL PERCENTAGES OF MEN, 

369
00:14:25,817 --> 00:14:27,819
6%. 

370
00:14:27,819 --> 00:14:28,419
AND CRITICALLY WE HEARD IN THIS 

371
00:14:28,419 --> 00:14:29,053
MEETING ABOUT YOUNG PEOPLE WHO 

372
00:14:29,053 --> 00:14:31,122
HAVE LONG COVID PARTICULARLY 

373
00:14:31,122 --> 00:14:34,292
KIDS AND TEENAGERS.  SOMETHING 

374
00:14:34,292 --> 00:14:34,826
THAT HAS BEEN VERY, VERY 

375
00:14:34,826 --> 00:14:37,528
UNDERAPPRECIATED. 

376
00:14:37,528 --> 00:14:38,129
ON AVERAGE WHEN YOU LOOK AT THE 

377
00:14:38,129 --> 00:14:39,297
DATA, WHEN YOU LOOK AT THESE 

378
00:14:39,297 --> 00:14:42,567
DATA, AND AT THE CDC'S PULSE 

379
00:14:42,567 --> 00:14:50,508
SURVEY PUBLISHED IN APRIL, IT 

380
00:14:50,508 --> 00:14:51,109
IS NOT TOTALLY INACCURATE TO 

381
00:14:51,109 --> 00:14:51,709
SAY THAT ABOUT 6-7% OF ADULTS 

382
00:14:51,709 --> 00:14:52,210
IN THE US ARE CURRENTLY 

383
00:14:52,210 --> 00:14:53,344
EXPERIENCE IN LONG COVID. 

384
00:14:53,344 --> 00:14:54,679
WE DO NOT KNOW WHAT THE DATA 

385
00:14:54,679 --> 00:14:57,482
OFFER PEOPLE YOUNGER THAN 20.  

386
00:14:57,482 --> 00:14:58,116
BUT IT IS HARD TO BELIEVE THAT 

387
00:14:58,116 --> 00:14:59,350
IT IS MUCH LOWER THAN THAT 

388
00:14:59,350 --> 00:15:02,153
BASED ON BOTH WHAT WE ARE 

389
00:15:02,153 --> 00:15:02,754
HEARING AND SOME MORE LIMITED 

390
00:15:02,754 --> 00:15:06,958
DATA THAT HAVE COME OUT. 

391
00:15:06,958 --> 00:15:07,525
SO, WHERE ARE WE NOW? CAN WE 

392
00:15:07,525 --> 00:15:12,297
PROJECT WHAT IS GOING TO HAPPEN?

393
00:15:12,297 --> 00:15:12,830
WE'VE OVERHEARING ABOUT THE 

394
00:15:12,830 --> 00:15:17,468
SUMMER WAVE; I PERSONALLY KNOW 

395
00:15:17,468 --> 00:15:20,672
ABOUT FOUR PEOPLE WHO ARE DONE 

396
00:15:20,672 --> 00:15:22,173
WITH COVID THIS WEEK IS PRETTY 

397
00:15:22,173 --> 00:15:29,314
MUCH EVERYWHERE YOU LOOK. THE 

398
00:15:29,314 --> 00:15:29,914
DATA SUGGEST WHICH AFTER THE 

399
00:15:29,914 --> 00:15:30,548
SUMMER WAVE WHICH CONTINUES TO 

400
00:15:30,548 --> 00:15:31,816
BE THE OFFSPRING OF THE OMICRON 

401
00:15:31,816 --> 00:15:32,450
FAMILY WE PROBABLY HAVE SEEN A 

402
00:15:32,450 --> 00:15:33,051
DOWNTURN. BUT WE DON'T KNOW 

403
00:15:33,051 --> 00:15:36,254
WHAT IS GOING HAPPEN. THIS IS A 

404
00:15:36,254 --> 00:15:39,691
VERY, VERY IN SOME WAYS 

405
00:15:39,691 --> 00:15:40,325
PREDICTABLE AS YOU CAN SEE FROM 

406
00:15:40,325 --> 00:15:40,958
THE PEAKS AND VALLEYS, BUT IN 

407
00:15:40,958 --> 00:15:42,794
SOME WAYS A VERY UNPREDICTABLE 

408
00:15:42,794 --> 00:15:46,331
VIRUS. WE HAVE BEEN FORTUNATE 

409
00:15:46,331 --> 00:15:48,433
ENOUGH TO SEE A VARIANCE, NOT 

410
00:15:48,433 --> 00:15:49,500
COVERED BY THE CURRENT BOOSTER 

411
00:15:49,500 --> 00:15:51,903
RECOMMENDATION. AND CERTAINLY 

412
00:15:51,903 --> 00:15:53,304
NOT RESISTANT TO PAX-LOVID AS 

413
00:15:53,304 --> 00:15:56,841
FAR AS WE KNOW. BUT IT IS STILL 

414
00:15:56,841 --> 00:15:57,475
SOMETHING THAT WE HAVE TO WORRY 

415
00:15:57,475 --> 00:15:58,643
ABOUT. 

416
00:15:58,643 --> 00:15:59,877
AND WHEN I TALKED WITH PEOPLE 

417
00:15:59,877 --> 00:16:02,547
ABOUT THE RISK OF GETTING COVID 

418
00:16:02,547 --> 00:16:03,114
IT IS NOT JUST THAT WE HAVE 

419
00:16:03,114 --> 00:16:04,749
DONE MUCH BETTER AT PREVENTING 

420
00:16:04,749 --> 00:16:07,852
SEVERE ILLNESS, LIKE 

421
00:16:07,852 --> 00:16:08,486
HOSPITALIZATIONS AND EVEN DEATH 

422
00:16:08,486 --> 00:16:10,154
WITH VACCINATION.  WE STILL 

423
00:16:10,154 --> 00:16:14,025
HAVEN'T PREVENTED LONG COVID 

424
00:16:14,025 --> 00:16:14,659
AND I WILL TALK ABOUT WHAT THE 

425
00:16:14,659 --> 00:16:16,127
DATA ARE FOR COVID VACCINE 

426
00:16:16,127 --> 00:16:21,632
PREVENTING LONG COVID. AND I 

427
00:16:21,632 --> 00:16:22,200
THINK THEY DO BUT THERE IS 

428
00:16:22,200 --> 00:16:25,002
STILL A SIGNIFICANT RISK THAT 

429
00:16:25,002 --> 00:16:25,603
YOU ARE GOING TO GET INFECTED 

430
00:16:25,603 --> 00:16:27,105
AND YOU MIGHT HAVE SET YOURSELF 

431
00:16:27,105 --> 00:16:29,874
UP FOR SOME CORRELATED LONG 

432
00:16:29,874 --> 00:16:33,211
COVID. 

433
00:16:33,211 --> 00:16:33,778
I DID NOT HAVE TIME TO MAKE A 

434
00:16:33,778 --> 00:16:36,013
SLIDE ON THIS, BUT ONE OF THE 

435
00:16:36,013 --> 00:16:36,647
PAPERS THAT CAME OUT THIS WEEK 

436
00:16:36,647 --> 00:16:38,583
AND THAT IS CHALLENGE, THE 

437
00:16:38,583 --> 00:16:39,450
FIELD IS MOVING REALLY FAST 

438
00:16:39,450 --> 00:16:44,489
NOW. WAS A PAPER IN NATURE  I 

439
00:16:44,489 --> 00:16:46,791
BELIEVE  THAT LOOKED AT 

440
00:16:46,791 --> 00:16:47,425
NEUROLOGICAL MANIFESTATIONS IN 

441
00:16:47,425 --> 00:16:48,226
PEOPLE WHO WERE HOSPITALIZED 

442
00:16:48,226 --> 00:16:51,529
WITH LONG COVID WILL AFTER THEY 

443
00:16:51,529 --> 00:16:53,331
WERE DISCHARGED. 

444
00:16:53,331 --> 00:16:57,101
BASICALLY IT SHOWED THAT THE 

445
00:16:57,101 --> 00:16:58,202
COGNITIVE DECLINE ASSOCIATED 

446
00:16:58,202 --> 00:17:02,940
WITH SEVERE COVID INFECTION 

447
00:17:02,940 --> 00:17:03,574
HOSPITALIZATION, WAS ASSOCIATED 

448
00:17:03,574 --> 00:17:05,843
WITH SEVERAL YEARS WORTH OF 

449
00:17:05,843 --> 00:17:09,547
NEUROLOGICAL AGING WAY BEYOND 

450
00:17:09,547 --> 00:17:10,181
WHAT THE TIMEFRAME WOULD BE IF 

451
00:17:10,181 --> 00:17:16,387
YOU HAVE NOT GOTTEN COVID. 

452
00:17:16,387 --> 00:17:16,921
SO I THINK AGAIN THE DATA A 

453
00:17:16,921 --> 00:17:18,189
REALLY STRONG THAT UNLESS YOU 

454
00:17:18,189 --> 00:17:19,891
CAN PREVENT THE VIRUS PROBABLY 

455
00:17:19,891 --> 00:17:26,431
FROM TRAVERSING THE OLFACTORY 

456
00:17:26,431 --> 00:17:27,031
NERVE, AND GETTING INTO YOUR 

457
00:17:27,031 --> 00:17:27,765
BRAIN ALMOST CERTAINLY, MAYBE 

458
00:17:27,765 --> 00:17:31,669
THROUGH OTHER MECHANISMS TOO, 

459
00:17:31,669 --> 00:17:32,270
YOU WILL NOT BE SUCCESSFUL IN 

460
00:17:32,270 --> 00:17:33,337
PREVENTING ENTRY INTO THE 

461
00:17:33,337 --> 00:17:34,906
CENTRAL NERVOUS SYSTEM. IT IS 

462
00:17:34,906 --> 00:17:36,908
VERY NERVE-RACKING. 

463
00:17:36,908 --> 00:17:40,678
LET'S TALK ABOUT THE 

464
00:17:40,678 --> 00:17:41,312
DEFINITION. YOU MAY HAVE HEARD 

465
00:17:41,312 --> 00:17:41,913
THAT THE NATIONAL ACADEMY OF 

466
00:17:41,913 --> 00:17:43,414
SCIENCES ENGINEERING IN 

467
00:17:43,414 --> 00:17:43,948
MEDICINE CAME UP WITH THE 

468
00:17:43,948 --> 00:17:45,082
DEFINITION JUST A COUPLE MONTHS 

469
00:17:45,082 --> 00:17:46,117
AGO. THAT IS NOT WHAT THIS IS 

470
00:17:46,117 --> 00:17:52,790
ABOUT. THE NASM DELUSION IS 

471
00:17:52,790 --> 00:17:53,458
INCREDIBLY INCLUSIVE DEFINITION 

472
00:17:53,458 --> 00:17:57,528
THAT DEFINES LONG COVID AS A 

473
00:17:57,528 --> 00:17:58,095
CASE WHERE A PERSON HAS HAD 

474
00:17:58,095 --> 00:18:06,003
SYMPTOMS COMPATIBLE WITH LONG 

475
00:18:06,003 --> 00:18:06,537
COVID, TACKING ON ALL THE 

476
00:18:06,537 --> 00:18:07,171
THINGS WE ARE TALKING ABOUT, AT 

477
00:18:07,171 --> 00:18:07,805
LEAST THREE MONTHS AFTER HAVING 

478
00:18:07,805 --> 00:18:09,941
LONG COVID AND PERSISTING OVER 

479
00:18:09,941 --> 00:18:14,579
TIME. IS VERY, VERY GENERAL. I 

480
00:18:14,579 --> 00:18:15,179
PROBABLY HAVE NOT GOTTEN THE 

481
00:18:15,179 --> 00:18:17,915
EXACT DETAIL OF THAT DEFINITION 

482
00:18:17,915 --> 00:18:18,416
RIGHT, BUT PARTLY IT IS 

483
00:18:18,416 --> 00:18:20,284
INCREDIBLY BROAD AND INCLUSIVE 

484
00:18:20,284 --> 00:18:24,021
INTERVIEW LISTEN TO THE FOLKS 

485
00:18:24,021 --> 00:18:24,622
AND READ THE REPORT THEY ARE 

486
00:18:24,622 --> 00:18:25,256
SAYING IS THEY WANTED SOMETHING 

487
00:18:25,256 --> 00:18:27,959
TO EMPOWER PATIENTS AND 

488
00:18:27,959 --> 00:18:28,526
CLINICIANS TO RECOGNIZE THE 

489
00:18:28,526 --> 00:18:33,364
BROAD NATURE OF LONG COVID.  

490
00:18:33,364 --> 00:18:33,998
BECAUSE A LOT OF PEOPLE MAY NOT 

491
00:18:33,998 --> 00:18:34,599
REALIZE THAT THE FATIGUE THEY 

492
00:18:34,599 --> 00:18:39,904
ARE SEEING, THE PALPITATIONS 

493
00:18:39,904 --> 00:18:40,538
THEY ARE FEELING, THE EXERTION 

494
00:18:40,538 --> 00:18:41,939
THEY'RE HAVING IS POTENTIALLY 

495
00:18:41,939 --> 00:18:42,540
RELATED TO A PREVIOUS EPISODE 

496
00:18:42,540 --> 00:18:43,674
OF COVID. 

497
00:18:43,674 --> 00:18:48,846
AND AGAIN THE NASM DEFINITION 

498
00:18:48,846 --> 00:18:49,447
IS NOT SOMETHING WE PROBABLY 

499
00:18:49,447 --> 00:18:50,848
WILL USE ON CLINICAL TRIALS. WE 

500
00:18:50,848 --> 00:18:54,285
NEED TO TALK ABOUT THAT. BUT 

501
00:18:54,285 --> 00:18:54,886
FOR CLINICAL TRIALS WHEN YOU 

502
00:18:54,886 --> 00:18:55,486
ARE TALKING ABOUT LOOKING AT 

503
00:18:55,486 --> 00:18:56,521
FUNCTIONAL IMPROVEMENT IN 

504
00:18:56,521 --> 00:18:58,789
PARTICULAR OR ENROLLMENT 

505
00:18:58,789 --> 00:18:59,357
CRITERIA YOU NEED TO THINK 

506
00:18:59,357 --> 00:19:00,458
ABOUT HOW YOU ARE GOING TO BE A 

507
00:19:00,458 --> 00:19:05,863
LITTLE MORE PRECISE. NOT TO BE 

508
00:19:05,863 --> 00:19:06,497
EXCLUSIONARY, BECAUSE WE HEARD 

509
00:19:06,497 --> 00:19:07,064
LOUD AND CLEAR THAT FOR THE 

510
00:19:07,064 --> 00:19:08,132
CLINICAL TRIALS WE WANT TO BE 

511
00:19:08,132 --> 00:19:08,733
OPEN TO AS MANY PEOPLE AS WE 

512
00:19:08,733 --> 00:19:09,934
POSSIBLY CAN. 

513
00:19:09,934 --> 00:19:12,470
BUT I WILL SHOW THIS. THIS IS 

514
00:19:12,470 --> 00:19:18,509
FROM RECOVER, AN NHLBI PROJECT 

515
00:19:18,509 --> 00:19:21,178
ALONG WITH NIAID.  THIS WAS 

516
00:19:21,178 --> 00:19:21,779
WHEN THE FIRST PAPERS IT CAN 

517
00:19:21,779 --> 00:19:23,948
MOUNT FROM RECOVER, LOOKING 

518
00:19:23,948 --> 00:19:30,655
CAREFULLY AT SYMPTOMS AND THEN 

519
00:19:30,655 --> 00:19:31,422
PROVIDING THEM OR CALCULATING 

520
00:19:31,422 --> 00:19:34,926
WHAT IS CALLED THE "PAST 

521
00:19:34,926 --> 00:19:38,996
SCORE," THE POSTACUTE 

522
00:19:38,996 --> 00:19:41,832
SARS-COV-2 DESIGNATION. 

523
00:19:41,832 --> 00:19:44,035
WHAT THE GROUP DID WAS THROUGH 

524
00:19:44,035 --> 00:19:46,571
EXTENSIVE ANALYSIS OF MANY, 

525
00:19:46,571 --> 00:19:49,774
MANY PEOPLE ALMOST 10,000 

526
00:19:49,774 --> 00:19:50,408
PARTICIPANTS OVER SIX MONTHS OF 

527
00:19:50,408 --> 00:19:53,945
FOLLOW-UP; NOT LONG, LONG COVID 

528
00:19:53,945 --> 00:19:57,315
BUT SIX MONTHS OF FOLLOW-UP. 

529
00:19:57,315 --> 00:19:57,915
LOOKING AT THE SYMPTOMS THAT 

530
00:19:57,915 --> 00:19:58,382
PREDICTED THE HIGHEST 

531
00:19:58,382 --> 00:20:00,051
LIKELIHOOD OF THIS SOMEWHAT 

532
00:20:00,051 --> 00:20:06,223
OBJECTIVELY DEFINED PASC. 

533
00:20:06,223 --> 00:20:06,757
AND WHAT THEY CONCLUDED WAS 

534
00:20:06,757 --> 00:20:11,796
THAT HIS SCORE OF 12 WAS 

535
00:20:11,796 --> 00:20:12,396
OPTIMAL FOR DEFINING THAT AND 

536
00:20:12,396 --> 00:20:15,766
YOU CAN SEE THAT ONE OF THE 

537
00:20:15,766 --> 00:20:16,367
MOST SPECIFIC SYMPTOMS WHICH 

538
00:20:16,367 --> 00:20:16,934
WE'VE KNOWN SINCE THE EARLY 

539
00:20:16,934 --> 00:20:20,605
DAYS OF THE PANDEMIC-- I 

540
00:20:20,605 --> 00:20:21,105
REMEMBER WALKING ON THE 

541
00:20:21,105 --> 00:20:21,739
HOSPITAL WARDS WITH OUR MASKS, 

542
00:20:21,739 --> 00:20:26,677
AND SEEING COFFEE BEANS THERE, 

543
00:20:26,677 --> 00:20:27,244
HE WAS SUPPOSED TO USE THE 

544
00:20:27,244 --> 00:20:27,812
COFFEE BEANS AS A SURROGATE 

545
00:20:27,812 --> 00:20:28,412
MEASURE OF WHETHER OR NOT YOU 

546
00:20:28,412 --> 00:20:29,046
COULD SMELL. THAT WAS PROBABLY 

547
00:20:29,046 --> 00:20:29,647
ONE OF THE FIRST THINGS THAT 

548
00:20:29,647 --> 00:20:31,882
PEOPLE KNEW WAS HAPPENING. 

549
00:20:31,882 --> 00:20:42,360
SO SMELL, TASTE, ASMEA, POST-- 

550
00:20:44,195 --> 00:20:44,729
MALAISE, ONE OF THE TOPIC YOU 

551
00:20:44,729 --> 00:20:47,932
WANT TO TALK ABOUT, EXECUTIVE 

552
00:20:47,932 --> 00:20:55,840
AREA AND THE POST SENSORY PART. 

553
00:20:55,840 --> 00:20:56,407
COGNITIVE BRAIN FOG. CHEST 

554
00:20:56,407 --> 00:20:59,176
PALPITATIONS. LOW SEXUAL 

555
00:20:59,176 --> 00:20:59,810
DESIRE. ABNORMAL MOVEMENTS AND 

556
00:20:59,810 --> 00:21:02,013
HAIR LOSS WAS LOOKED UP. 

557
00:21:02,013 --> 00:21:05,483
SO THOSE ARE THE COMPOSITE 

558
00:21:05,483 --> 00:21:06,117
SCORES. YOU CAN SEE THAT IF YOU 

559
00:21:06,117 --> 00:21:08,786
HAD SIGNIFICANT MALAISE, AND 

560
00:21:08,786 --> 00:21:10,388
SMELL OR TASTE DISORDERS YOU 

561
00:21:10,388 --> 00:21:11,722
ALREADY HAVE A COMPLEX GOING TO 

562
00:21:11,722 --> 00:21:18,195
GET YOU ABOVE THE MEAN.

563
00:21:18,195 --> 00:21:19,664
HOW USEFUL IS THIS IN ENROLLING 

564
00:21:19,664 --> 00:21:20,264
PEOPLE IN CLINICAL TRIALS? IT 

565
00:21:20,264 --> 00:21:20,898
WILL BE INTERESTING TO SEE. WE 

566
00:21:20,898 --> 00:21:22,333
NEED TO DISCUSS THAT. 

567
00:21:22,333 --> 00:21:22,867
I MENTIONED THE ISSUE AS TO 

568
00:21:22,867 --> 00:21:23,501
WHETHER VACCINATION REDUCES THE 

569
00:21:23,501 --> 00:21:26,604
RISK OF LONG COVID.  AND I 

570
00:21:26,604 --> 00:21:28,406
WOULD SAY THAT YOU CAN FIND 

571
00:21:28,406 --> 00:21:32,743
SORT OF VARIOUS ANALYSES TO 

572
00:21:32,743 --> 00:21:34,478
SUPPORT EITHER TAKE ON THIS.  

573
00:21:34,478 --> 00:21:35,780
BUT I LIKE THIS PAPER BY 

574
00:21:35,780 --> 00:21:40,484
BRANNOCK ET AL BECAUSE IT 

575
00:21:40,484 --> 00:21:43,287
REALLY WAS ABLE TO LOOK AT A 

576
00:21:43,287 --> 00:21:46,157
HUGE NUMBER OF PEOPLE, MODELING 

577
00:21:46,157 --> 00:21:49,226
A COHORT HERE. 

578
00:21:49,226 --> 00:21:49,794
YOU CAN SEE THE NUMBERS DOWN 

579
00:21:49,794 --> 00:21:52,029
THERE ARE QUITE SMALL.  LOOKING 

580
00:21:52,029 --> 00:21:59,537
AT POTENTIAL 109,000 VACCINATED 

581
00:21:59,537 --> 00:22:00,071
VERSUS 78,000 VACCINATED 

582
00:22:00,071 --> 00:22:03,874
FOLLOWING THEM FOR ABOUT A YEAR 

583
00:22:03,874 --> 00:22:05,710
FOR THE LIKELIHOOD OF PASC OR 

584
00:22:05,710 --> 00:22:07,545
LONG COVID. 

585
00:22:07,545 --> 00:22:11,215
THIS IS MODELED ON THE DATA 

586
00:22:11,215 --> 00:22:13,317
FROM ELECTRONIC HEALTH RECORDS. 

587
00:22:13,317 --> 00:22:16,454
 AND WE ALL RECOGNIZE ANYBODY 

588
00:22:16,454 --> 00:22:17,088
WHO HAS EVER WRITTEN A NOTE ON 

589
00:22:17,088 --> 00:22:27,631
THE PATIENT, IF YOU DO NOT SEE 

590
00:22:29,767 --> 00:22:30,234
PATIENTS, AND YOU HAVE TO 

591
00:22:30,234 --> 00:22:30,835
ANALYZE THE RECORDS YOU KNOW 

592
00:22:30,835 --> 00:22:32,269
WHAT LIMITATIONS ARE. THERE 

593
00:22:32,269 --> 00:22:34,472
OFTEN BUILT FROM BILLING. LOTS 

594
00:22:34,472 --> 00:22:35,106
OF COPY PASTE GOING ON; LOTS OF 

595
00:22:35,106 --> 00:22:37,508
NOISE, LOTS OF GARBAGE. 

596
00:22:37,508 --> 00:22:39,710
BUT FROM SOME KEY DIAGNOSIS AND 

597
00:22:39,710 --> 00:22:40,244
SOME SPECIFIC THEY CAN BE 

598
00:22:40,244 --> 00:22:46,951
INCREDIBLY USEFUL. WHEN YOU 

599
00:22:46,951 --> 00:22:47,485
HAVE A BINARY VARIABLE OF 

600
00:22:47,485 --> 00:22:48,119
VACCINATION VERSUS NOT, YOU CAN 

601
00:22:48,119 --> 00:22:54,158
MODEL THINGS TO HELP WITH 

602
00:22:54,158 --> 00:22:54,725
SUPPOSITION PREDICTING THE 

603
00:22:54,725 --> 00:22:55,326
OUTCOMES. END WHAT THIS GROUP 

604
00:22:55,326 --> 00:22:56,160
SHOWED IS THAT YOU DID REDUCE 

605
00:22:56,160 --> 00:22:59,864
THE PROBABILITY OF LONG COVID 

606
00:22:59,864 --> 00:23:00,464
SIGNIFICANTLY WHICH IS OWNED 

607
00:23:00,464 --> 00:23:02,066
SHOWN THERE AND I THINK MOST 

608
00:23:02,066 --> 00:23:02,666
OTHER ANALYSES HAVE SUPPORTED 

609
00:23:02,666 --> 00:23:06,837
THIS. 

610
00:23:06,837 --> 00:23:07,404
AGAIN IT DEPENDS ON WHEN YOU 

611
00:23:07,404 --> 00:23:08,005
GOT VACCINATED, WHICH VACCINE 

612
00:23:08,005 --> 00:23:10,941
YOU GOT, HOW MANY BOOSTERS YOU 

613
00:23:10,941 --> 00:23:11,575
GOT, WHEN YOU WERE SUSCEPTIBLE 

614
00:23:11,575 --> 00:23:13,244
TO WHICH VARIANT, AND WHAT YOUR 

615
00:23:13,244 --> 00:23:15,412
PREDILECTION FOR LONG COVID WAS 

616
00:23:15,412 --> 00:23:19,483
IN THE FIRST PLACE. 

617
00:23:19,483 --> 00:23:20,084
AGAIN THERE IS ALMOST NO SIMPLE 

618
00:23:20,084 --> 00:23:20,584
ANSWER TO ANY OF THESE 

619
00:23:20,584 --> 00:23:22,520
QUESTIONS.  AND I REALLY WANT 

620
00:23:22,520 --> 00:23:24,989
TO KEEP COMING BACK TO THAT; IS 

621
00:23:24,989 --> 00:23:28,225
ONE OF THE THINGS THAT FUELS 

622
00:23:28,225 --> 00:23:28,826
MISINFORMATION. YOU CAN FIND 

623
00:23:28,826 --> 00:23:29,426
EVIDENCE TO SUPPORT VERY MUCH 

624
00:23:29,426 --> 00:23:35,633
ANY OF VIEW HERE. AND THERE ARE 

625
00:23:35,633 --> 00:23:36,267
REASONS WHY THE EVIDENCE IS NOT 

626
00:23:36,267 --> 00:23:36,700
WATERTIGHT. 

627
00:23:36,700 --> 00:23:40,838
WE TALKED ABOUT PATHOGENESIS.  

628
00:23:40,838 --> 00:23:41,405
I'M GOING TO SHOW YOU A FEW 

629
00:23:41,405 --> 00:23:42,673
STUDIES THAT I THINK ADDRESS 

630
00:23:42,673 --> 00:23:49,480
EACH OF THESE MAJOR CATEGORIES. 

631
00:23:49,480 --> 00:23:49,947
SO VIRAL REACTIVATION, 

632
00:23:49,947 --> 00:23:51,882
PERSISTENT VIRAL INFECTION-- 

633
00:23:51,882 --> 00:23:52,917
MEANING YOU'VE GOT COMPONENTS 

634
00:23:52,917 --> 00:23:54,952
OF ANTIGENIC, IMMUNOGENIC VIRUS 

635
00:23:54,952 --> 00:23:58,389
THERE -- OR IMMUNE 

636
00:23:58,389 --> 00:24:03,894
DYSREGULATION PERHAPS WITH SOME 

637
00:24:03,894 --> 00:24:10,267
SUB- MECHANISMS OR MACROPHAGE 

638
00:24:10,267 --> 00:24:10,868
ACTIVATION, THE BIG BUCKETS. 

639
00:24:10,868 --> 00:24:11,468
LET'S TAKE A LOOK AT EACH OF 

640
00:24:11,468 --> 00:24:12,536
THESE.

641
00:24:12,536 --> 00:24:14,238
THERE ARE A LOT OF PAPERS; 

642
00:24:14,238 --> 00:24:15,973
THERE IS NO WAY WE CAN 

643
00:24:15,973 --> 00:24:17,174
GOVERNMENT 45 MINUTES. I DO 

644
00:24:17,174 --> 00:24:17,675
WANT TO LEAVE TIME FOR 

645
00:24:17,675 --> 00:24:18,309
QUESTIONS BECAUSE THERE ARE SO 

646
00:24:18,309 --> 00:24:20,377
MANY QUESTIONS. 

647
00:24:20,377 --> 00:24:20,945
ONE OF THE FIRST PAPERS THAT 

648
00:24:20,945 --> 00:24:22,746
CAME OUT THAT WAS PRETTY 

649
00:24:22,746 --> 00:24:26,183
INDISPUTABLE AND GOT PEOPLE'S 

650
00:24:26,183 --> 00:24:26,750
ATTENTION EARLY-- EVEN WHEN 

651
00:24:26,750 --> 00:24:27,351
PEOPLE WERE DISPUTING WHETHER 

652
00:24:27,351 --> 00:24:28,018
THERE WAS SUCH A THING AS LONG 

653
00:24:28,018 --> 00:24:30,421
COVID. RIGHT?

654
00:24:30,421 --> 00:24:31,989
ONE OF THE GREAT THINGS ABOUT 

655
00:24:31,989 --> 00:24:33,624
THIS MEETING WAS THAT WE HAD 

656
00:24:33,624 --> 00:24:37,294
SEVERAL PROVIDERS WHO TALKED 

657
00:24:37,294 --> 00:24:38,195
ABOUT HAVING TO CONFRONT 

658
00:24:38,195 --> 00:24:43,901
SKEPTICISM ABOUT LONG COVID AND 

659
00:24:43,901 --> 00:24:51,442
CHRONIC FATIGUE SYNDROME, AND 

660
00:24:51,442 --> 00:24:55,946
MYONIC ENCEPHALITIS. IT WAS 

661
00:24:55,946 --> 00:24:56,547
INFORMED BY THEIR BELIEF THAT 

662
00:24:56,547 --> 00:24:57,081
THESE WERE PSYCHOSOMATIC 

663
00:24:57,081 --> 00:24:57,681
CONDITIONS; TALKING TO PEOPLE 

664
00:24:57,681 --> 00:25:00,417
WITH LONG COVID IN PARTICULAR 

665
00:25:00,417 --> 00:25:04,221
AND HAVING THE WINDOW INTO 

666
00:25:04,221 --> 00:25:04,788
THESE INFECTION ASSOCIATED 

667
00:25:04,788 --> 00:25:05,322
CHRONIC CONDITIONS REALLY 

668
00:25:05,322 --> 00:25:05,890
CHANGED HER MIND ABOUT WHAT 

669
00:25:05,890 --> 00:25:09,660
PEOPLE WERE DEALING WITH. 

670
00:25:09,660 --> 00:25:10,227
AND I THINK THIS PAPER-- YOU 

671
00:25:10,227 --> 00:25:15,599
DON'T HAVE TO GO GET BRAIN 

672
00:25:15,599 --> 00:25:16,166
BIOPSIES TO PROVE THAT THE 

673
00:25:16,166 --> 00:25:19,670
COMMUNICATION WAS RIGHT WAS 

674
00:25:19,670 --> 00:25:20,237
IMPORTANT INVALIDATING WHAT 

675
00:25:20,237 --> 00:25:20,971
SOME OF THESE HYPOTHESES ARE. 

676
00:25:20,971 --> 00:25:30,948
THESE WERE AUTOPSIES ON 44 

677
00:25:30,948 --> 00:25:31,482
COVID PATIENTS FROM ACUTE 

678
00:25:31,482 --> 00:25:32,116
INFECTIONS, SEVEN MONTHS FROM 

679
00:25:32,116 --> 00:25:34,418
THE ONSET. YOU CAN FIND THE 

680
00:25:34,418 --> 00:25:37,254
VIRUS WIDELY DISTRIBUTED EVEN 

681
00:25:37,254 --> 00:25:37,688
IN PATIENTS WITHOUT 

682
00:25:37,688 --> 00:25:38,155
ASYMPTOMATIC OR MILD 

683
00:25:38,155 --> 00:25:38,589
INFECTIONS. 

684
00:25:38,589 --> 00:25:41,625
THEY HAD COVID, THEY APPEARED 

685
00:25:41,625 --> 00:25:44,128
TO GET BETTER. AND WENT ON TO 

686
00:25:44,128 --> 00:25:48,232
DIE OF SOMETHING ELSE. 

687
00:25:48,232 --> 00:25:51,969
THIS GROUP WAS ABLE TO SHOW 

688
00:25:51,969 --> 00:25:53,270
THAT REPLICATION WAS PRESENT; 

689
00:25:53,270 --> 00:25:53,871
PARTICULARLY IN PULMONARY AND 

690
00:25:53,871 --> 00:25:54,438
EXTRA PULMONARY TISSUES IN 

691
00:25:54,438 --> 00:25:54,905
EARLY INFECTION. NOT 

692
00:25:54,905 --> 00:25:55,940
SURPRISING. 

693
00:25:55,940 --> 00:25:58,709
BUT THEN THEY WENT ON TO LOOK 

694
00:25:58,709 --> 00:26:02,413
FOR RNA IN MULTIPLE SITES 

695
00:26:02,413 --> 00:26:03,013
INCLUDING THE BRAIN, AND THEY 

696
00:26:03,013 --> 00:26:04,815
WERE ABLE TO FIND UP TO 230 

697
00:26:04,815 --> 00:26:09,887
DAYS AFTER SYMPTOMS, BECAUSE 

698
00:26:09,887 --> 00:26:10,521
THE PEOPLE'S ATTENTION BECAUSE 

699
00:26:10,521 --> 00:26:11,088
IF YOU STILL HAVE THE VIRUS 

700
00:26:11,088 --> 00:26:11,655
PRESENT IN THE BRAIN, THE 

701
00:26:11,655 --> 00:26:14,391
ANTIGEN IS STILL THERE. 

702
00:26:14,391 --> 00:26:14,892
INTERESTINGLY THERE WAS A 

703
00:26:14,892 --> 00:26:25,436
POSSIBILITY OF INFLAMMATION OR 

704
00:26:26,003 --> 00:26:26,570
VIRAL CYTOPATHOLOGY OUTSIDE THE 

705
00:26:26,570 --> 00:26:31,241
LONG. 

706
00:26:31,241 --> 00:26:31,809
THE QUESTIONS THAT IS REALLY 

707
00:26:31,809 --> 00:26:32,443
RAISED AND THE CONCLUSIONS ARE 

708
00:26:32,443 --> 00:26:33,043
PRETTY WELL EXCEPT NOW, BUT 

709
00:26:33,043 --> 00:26:35,913
STILL VERY VALID. CLEARLY THE 

710
00:26:35,913 --> 00:26:36,513
VIRUS IS ABLE TO INFECT MANY 

711
00:26:36,513 --> 00:26:40,617
CELL TYPES; CORRELATES WITH 

712
00:26:40,617 --> 00:26:41,251
DIVERSE PATHOLOGIES GOING BACK 

713
00:26:41,251 --> 00:26:42,252
TO THAT EARLY SLIDE I SHOWED 

714
00:26:42,252 --> 00:26:44,755
YOU. BUT WE STILL DON'T KNOW 

715
00:26:44,755 --> 00:26:45,322
WHETHER THE PERSISTENCE OF 

716
00:26:45,322 --> 00:26:47,791
VIRUS PROTEINS OR VIRAL RNA IS 

717
00:26:47,791 --> 00:26:51,228
CORRELATED WITH LONG COVID. OR 

718
00:26:51,228 --> 00:26:54,031
THE CLINICAL COURSE OF DISEASE. 

719
00:26:54,031 --> 00:26:54,832
THIS IS A HUGE QUESTION RIGHT 

720
00:26:54,832 --> 00:26:55,466
NOW UNDER INTENSE INVESTIGATION 

721
00:26:55,466 --> 00:26:58,736
WITH NIH RECOVER AND ALSO IN 

722
00:26:58,736 --> 00:27:00,037
CLINICAL TRIALS WHICH I HOPE TO 

723
00:27:00,037 --> 00:27:02,072
TALK ABOUT IF WE HAVE TIME AT 

724
00:27:02,072 --> 00:27:04,208
THE END. 

725
00:27:04,208 --> 00:27:11,615
SO, A COUPLE OF PATHWAYS OF 

726
00:27:11,615 --> 00:27:12,116
INTERROGATION THAT HAVE 

727
00:27:12,116 --> 00:27:14,385
ADDRESSED THIS ONE. AND THIS I 

728
00:27:14,385 --> 00:27:17,921
THINK IS ONE OF THE MORE 

729
00:27:17,921 --> 00:27:18,856
PROVOCATIVE RECENT PAPERS. 

730
00:27:18,856 --> 00:27:22,960
AGAIN FROM MIKE PELUSO AND HIS 

731
00:27:22,960 --> 00:27:25,396
GROUP AT STANFORD, LANCET 

732
00:27:25,396 --> 00:27:32,770
INFECT DIS. THE LANCET GROUP 

733
00:27:32,770 --> 00:27:33,404
WAS AHEAD OF THE CURVE GETTING 

734
00:27:33,404 --> 00:27:34,738
THE SAMPLES EARLY ON, AND 

735
00:27:34,738 --> 00:27:35,339
ASKING CRITICAL QUESTIONS AND 

736
00:27:35,339 --> 00:27:38,776
THEY HAD 171 ADULTS AT SEVERAL 

737
00:27:38,776 --> 00:27:39,476
TIME POINTS IN 14 MONTHS 

738
00:27:39,476 --> 00:27:42,479
FOLLOWING RNA CONFIRMED 

739
00:27:42,479 --> 00:27:43,080
SARS-COV-2 INFECTION SO THEY 

740
00:27:43,080 --> 00:27:44,982
CLEARLY HAD VIRALLY CONFIRMED 

741
00:27:44,982 --> 00:27:46,216
INFECTION, ANOTHER CHALLENGE 

742
00:27:46,216 --> 00:27:49,053
WITH DOING LONG COVID STUDIES 

743
00:27:49,053 --> 00:27:49,653
BECAUSE SOMEBODY MAY COME IN 

744
00:27:49,653 --> 00:27:53,424
AND CLEARLY HAVE LONG COVID, 

745
00:27:53,424 --> 00:27:54,024
ARE YOU ABLE GOING TO DETECT 

746
00:27:54,024 --> 00:27:55,759
SIGNS OF THE VIRUS EASILY IN 

747
00:27:55,759 --> 00:27:58,395
THE PLASMA OR ANYWHERE ELSE? 

748
00:27:58,395 --> 00:27:59,229
MAYBE NOT. WE WILL COME BACK TO 

749
00:27:59,229 --> 00:28:04,668
THAT IF WE HAVE TIME. 

750
00:28:04,668 --> 00:28:05,269
MAY THEN COMPARE THIS PEOPLE TO 

751
00:28:05,269 --> 00:28:07,938
250 ADULTS WAS PLASMA WAS 

752
00:28:07,938 --> 00:28:08,572
COLLECTED BEFORE THE PANDEMIC. 

753
00:28:08,572 --> 00:28:10,874
THE BEAUTY OF HAVING BIO 

754
00:28:10,874 --> 00:28:11,475
DEPOSITORIES. YOU CAN ASK THE 

755
00:28:11,475 --> 00:28:12,109
QUESTIONS ABOUT WHAT WAS GOING 

756
00:28:12,109 --> 00:28:14,244
ON BEFORE 2020. THESE PEOPLE 

757
00:28:14,244 --> 00:28:15,045
HAD PURPORTEDLY NEVER BEEN 

758
00:28:15,045 --> 00:28:19,516
EXPOSED TO SARS-COV-2. 

759
00:28:19,516 --> 00:28:20,150
THEY USED A SINGLE MOLECULE 

760
00:28:20,150 --> 00:28:24,221
ARRAY DETECTION PLATFORM CALLED 

761
00:28:24,221 --> 00:28:34,098
QUANTERIX (PHONETIC) TO 

762
00:28:34,098 --> 00:28:34,731
EVALUATE WHAT THE PREVALENCE OF 

763
00:28:34,731 --> 00:28:39,937
ANTIGENEMA WAS IN PLASMA. WHAT 

764
00:28:39,937 --> 00:28:40,437
YOU CAN SEE HERE IS THE 

765
00:28:40,437 --> 00:28:41,805
PRE-PANDEMIC IT WAS A NEGLIGENT 

766
00:28:41,805 --> 00:28:44,508
SIGNAL WITHIN THE RANGE OF 

767
00:28:44,508 --> 00:28:48,979
ERROR FALSE POSITIVITY AND 3 TO 

768
00:28:48,979 --> 00:28:55,719
6 MONTHS YOU HAVE 5.4% AND 

769
00:28:55,719 --> 00:28:58,455
10-14 MONTHS ABOUT 7%. 

770
00:28:58,455 --> 00:28:58,989
THE CONCEPT AS YOU PROBABLY 

771
00:28:58,989 --> 00:29:04,495
HAVE PERSISTENT ANTENIMA IS 

772
00:29:04,495 --> 00:29:13,604
FOLKS. WHAT WAS HE DOING?

773
00:29:13,604 --> 00:29:14,138
THEY WERE ABLE TO SHOW THE 

774
00:29:14,138 --> 00:29:14,738
PRESENCE OF THE VIRUS IN THE 

775
00:29:14,738 --> 00:29:15,572
GUT THEY GOT A HUGE AMOUNT OF 

776
00:29:15,572 --> 00:29:16,206
ATTENTION. NOBODY HAD LOOKED AT 

777
00:29:16,206 --> 00:29:20,043
THE GUT BEFORE. IT HAD NOT BEEN 

778
00:29:20,043 --> 00:29:23,947
SHOWN SO PERSUASIVELY IN SUCH A 

779
00:29:23,947 --> 00:29:24,548
WELL-CHARACTERIZED COHORT OF 

780
00:29:24,548 --> 00:29:25,482
HUMANS TO REALLY INDICATE THAT 

781
00:29:25,482 --> 00:29:26,083
THERE WAS SOMETHING GOING ON 

782
00:29:26,083 --> 00:29:27,951
HERE. 

783
00:29:27,951 --> 00:29:29,419
SO STILL NEEDED THOUGH, IS WHAT 

784
00:29:29,419 --> 00:29:34,758
ARE THE CLINICAL CORRELANTS OF 

785
00:29:34,758 --> 00:29:43,000
SARS-COV-2 AND PERSISTENCE, AND 

786
00:29:43,000 --> 00:29:43,634
IS THERE EVIDENCE OF PERSISTENT 

787
00:29:43,634 --> 00:29:45,269
VIRAL REPLICATION?

788
00:29:45,269 --> 00:29:54,411
WHAT ABOUT THE IMMUNE PROFILE 

789
00:29:54,411 --> 00:29:55,012
INVOKES? HOW DO WE KNOW THAT 

790
00:29:55,012 --> 00:29:55,646
IMMUNE DYSREGULATION MIGHT PLAY 

791
00:29:55,646 --> 00:29:56,013
A ROLE?

792
00:29:56,013 --> 00:29:58,815
ANALYZE PAPER FROM NATURE 

793
00:29:58,815 --> 00:30:00,918
FAMILIAR BEFORE LOOKED AT 

794
00:30:00,918 --> 00:30:03,520
PEOPLE WITH LONG COVID AND 

795
00:30:03,520 --> 00:30:06,356
THOSE WITHOUT AND THIS IS FROM 

796
00:30:06,356 --> 00:30:12,229
AKIKO OSAKI'S GROUP (PHONETIC), 

797
00:30:12,229 --> 00:30:13,463
THEY LOOK AT SEVERAL MARKERS OF 

798
00:30:13,463 --> 00:30:14,131
INFLAMMATION OR POTENTIAL 

799
00:30:14,131 --> 00:30:17,301
PATHWAYS FOR PERSISTENT IMMUNE 

800
00:30:17,301 --> 00:30:20,637
SIGNALING IN PEOPLE WITH LONG 

801
00:30:20,637 --> 00:30:22,573
COVID, AND THOSE WITHOUT. 

802
00:30:22,573 --> 00:30:23,073
AGAIN WELL-CHARACTERIZED 

803
00:30:23,073 --> 00:30:26,109
GROUPS.  AND SOME OF THE THINGS 

804
00:30:26,109 --> 00:30:26,677
THAT YOU CAN SEE THAT WERE 

805
00:30:26,677 --> 00:30:31,715
HIGHER IN LONG COVID WERE 

806
00:30:31,715 --> 00:30:35,953
SEVERAL THINGS THAT SUGGEST AN 

807
00:30:35,953 --> 00:30:39,723
EXAGGERATED SPECIFIC. HUMORAL 

808
00:30:39,723 --> 00:30:46,363
RESPONSE, CIRCULATING MYELOID 

809
00:30:46,363 --> 00:30:46,964
RESPONSES;  LIMITED SELECTED 

810
00:30:46,964 --> 00:30:47,531
ANTIBODIES AND EVIDENCE OF 

811
00:30:47,531 --> 00:30:51,435
HERPESVIRUS NAMELY EBV 

812
00:30:51,435 --> 00:30:52,002
ACTIVATION AS WE MENTIONED 

813
00:30:52,002 --> 00:30:55,439
BEFORE. AND LOW CORTISOL, 

814
00:30:55,439 --> 00:30:56,073
INTERESTING INFORMATION IN SOME 

815
00:30:56,073 --> 00:30:56,607
OF THE MEETING TALK ABOUT 

816
00:30:56,607 --> 00:31:03,213
VARIATIONS IN DAYTIME CYCLE 

817
00:31:03,213 --> 00:31:03,880
COVID SYMPTOMS THAT ARE BEYOND 

818
00:31:03,880 --> 00:31:10,754
WHAT WE KNOW ARE THE CYCLES OF 

819
00:31:10,754 --> 00:31:11,321
CORTISOL, IN EARLY-MORNING 

820
00:31:11,321 --> 00:31:11,955
AWAKENING, AND CORTISOL LEVELS 

821
00:31:11,955 --> 00:31:13,090
BEING HIGH IN THE MORNING.

822
00:31:13,090 --> 00:31:13,523
I THINK THIS IS QUITE 

823
00:31:13,523 --> 00:31:16,126
INTERESTING. THIS DOES SUGGEST 

824
00:31:16,126 --> 00:31:19,229
THAT THERE IS SOME IMMUNE 

825
00:31:19,229 --> 00:31:19,863
REGULATION; AND I THINK THIS IS 

826
00:31:19,863 --> 00:31:20,430
BEING ACTIVELY PURSUED AS A 

827
00:31:20,430 --> 00:31:24,167
POSSIBLE ONE. 

828
00:31:24,167 --> 00:31:25,702
AND THE OTHER SIDE OF IMMUNE 

829
00:31:25,702 --> 00:31:28,438
DYSREGULATION IS AUTOIMMUNITY. 

830
00:31:28,438 --> 00:31:31,174
AND I THINK THAT THERE ARE 

831
00:31:31,174 --> 00:31:33,277
SOMEWHAT FEWER INVESTIGATIONS 

832
00:31:33,277 --> 00:31:36,046
THAT HAVE GONE DOWN THIS ROAD.  

833
00:31:36,046 --> 00:31:36,647
BUT I DON'T THING IT HAS BEEN 

834
00:31:36,647 --> 00:31:40,684
RULED OUT YET. JUST A COUPLE OF 

835
00:31:40,684 --> 00:31:41,218
PAPERS YET, AGAIN IN THE 

836
00:31:41,218 --> 00:31:47,691
INTEREST OF TIME THAT SUGGESTED 

837
00:31:47,691 --> 00:31:48,258
THAT THERE MAY BE MOLECULAR 

838
00:31:48,258 --> 00:31:48,892
MIMICRY BETWEEN CROSS REACTION 

839
00:31:48,892 --> 00:31:50,360
ANTIBODIES AND HOST PROTEINS 

840
00:31:50,360 --> 00:31:50,961
PARTICULARLY THE SARS-COV-2 

841
00:31:50,961 --> 00:31:52,696
PROTEIN. 

842
00:31:52,696 --> 00:31:53,196
PROBABLY ONE OF THE BEST 

843
00:31:53,196 --> 00:31:57,100
EXAMPLES OF THIS IS MISC  IN 

844
00:31:57,100 --> 00:31:57,734
CHILDREN AND WE THINK THIS MAY 

845
00:31:57,734 --> 00:31:59,503
PLAY A ROLE THERE.  IS UNCLEAR 

846
00:31:59,503 --> 00:32:01,405
WHETHER THAT IS RELATED TO THE 

847
00:32:01,405 --> 00:32:05,208
LIKELIHOOD OF LONG COVID AND 

848
00:32:05,208 --> 00:32:06,910
AGAIN I AM NOT A PEDIATRIC 

849
00:32:06,910 --> 00:32:07,544
IMMUNOLOGIST, BUT I THINK THAT 

850
00:32:07,544 --> 00:32:09,913
IS A VERY FERTILE GROUND AREA 

851
00:32:09,913 --> 00:32:10,547
TO LOOK AT, SINCE THE WAY THAT 

852
00:32:10,547 --> 00:32:13,884
THOSE KIDS PRESENTED WITH MISC 

853
00:32:13,884 --> 00:32:14,518
IS VERY DIFFERENTLY WHAT WE ARE 

854
00:32:14,518 --> 00:32:15,719
TALKING ABOUT HERE. 

855
00:32:15,719 --> 00:32:23,994
AND THEN, AUTO ANTIGEN PROFILE 

856
00:32:23,994 --> 00:32:27,197
LOOKING AT AT LONG COVID 

857
00:32:27,197 --> 00:32:30,834
PATIENT THAT WAS A LITTLE LESS 

858
00:32:30,834 --> 00:32:31,368
CLEAR-- AND SORRY FOR NOT 

859
00:32:31,368 --> 00:32:34,338
PRODUCING THE DETAILS-- BUT IT 

860
00:32:34,338 --> 00:32:36,073
HAS BEEN USED A LITTLE BIT TO 

861
00:32:36,073 --> 00:32:36,707
SAY WELL I DON'T THINK THIS IS 

862
00:32:36,707 --> 00:32:40,077
ACTUALLY PLAYING A ROLE. 

863
00:32:40,077 --> 00:32:40,644
SO AGAIN GOING BACK TO THOSE 

864
00:32:40,644 --> 00:32:41,712
THREE BIG MECHANISMS, HUGE 

865
00:32:41,712 --> 00:32:47,584
AMOUNT OF CONFUSION.  SOME 

866
00:32:47,584 --> 00:32:48,151
COALESCENCE AROUND CERTAIN 

867
00:32:48,151 --> 00:32:52,456
PRINCIPLES. BUT TONS OF WORK TO 

868
00:32:52,456 --> 00:32:52,956
DO. AND WHY IS THIS SO 

869
00:32:52,956 --> 00:32:55,859
IMPORTANT TO RECOVERED TLC?

870
00:32:55,859 --> 00:33:03,200
RECOVERED TLC IS RECOVERED LONG 

871
00:33:03,200 --> 00:33:03,667
COVID; IT WILL BUILD 

872
00:33:03,667 --> 00:33:04,201
UNRECOVERED SUCCESSES AND 

873
00:33:04,201 --> 00:33:04,768
LESSONS LEARNED AND WHAT WE 

874
00:33:04,768 --> 00:33:05,268
WANT TO DO IS TEST MORE 

875
00:33:05,268 --> 00:33:07,204
POTENTIAL TREATMENTS FOR LONG 

876
00:33:07,204 --> 00:33:07,838
COVID SYMPTOMS ARE THE CHANCES 

877
00:33:07,838 --> 00:33:14,911
GOING TO BE HOW DO WE DECIDE 

878
00:33:14,911 --> 00:33:15,412
WHAT TO TARGET WHEN THE 

879
00:33:15,412 --> 00:33:15,979
PATHOBIOLOGY IS POTENTIALLY 

880
00:33:15,979 --> 00:33:19,750
MULTIFACTORIAL? POTENTIALLY 

881
00:33:19,750 --> 00:33:20,350
DISTINCTIVE DEPENDING ON THE 

882
00:33:20,350 --> 00:33:23,954
SYMPTOM COMPLEX; AND NOT ALWAYS 

883
00:33:23,954 --> 00:33:30,560
PERHAPS DRUG-TARGETABLE, OR 

884
00:33:30,560 --> 00:33:31,128
DRUGGABLE PEOPLE SAY. LET'S 

885
00:33:31,128 --> 00:33:33,497
TALK A LITTLE BIT ABOUT THAT. I 

886
00:33:33,497 --> 00:33:34,464
WOULD LIKE TO SPEND AT LEAST 20 

887
00:33:34,464 --> 00:33:39,936
MINUTES OR SO HEARING YOUR 

888
00:33:39,936 --> 00:33:40,570
THOUGHTS. I SUSPECT THIS GROUP 

889
00:33:40,570 --> 00:33:41,204
HAS THOUGHT ABOUT THIS QUITE A 

890
00:33:41,204 --> 00:33:46,176
LOT. 

891
00:33:46,176 --> 00:33:46,777
SO THIS IS A QUICK DESCRIPTION 

892
00:33:46,777 --> 00:33:54,251
OF  RECOVER-TLC, AND WE WANT TO 

893
00:33:54,251 --> 00:33:54,885
DEVELOP EFFECTIVE AND EFFICIENT 

894
00:33:54,885 --> 00:34:01,425
THERAPIES FOR LONG COVID.  WE 

895
00:34:01,425 --> 00:34:01,958
WOULD REALLY LIKE TO LEAN 

896
00:34:01,958 --> 00:34:02,592
PHARMACOLOGIC SIDE, AND I WILL 

897
00:34:02,592 --> 00:34:04,761
COME BACK TO WHY THAT IS 

898
00:34:04,761 --> 00:34:05,262
CHALLENGING. WE WANT TO 

899
00:34:05,262 --> 00:34:06,730
DEFINITELY NOT REINVENT THE 

900
00:34:06,730 --> 00:34:07,330
WHEEL, BUILD ON THE FINDINGS 

901
00:34:07,330 --> 00:34:12,002
FROM THE RECOVERED COHORTS. 

902
00:34:12,002 --> 00:34:12,636
THERE PEOPLE WHO HAVE PROPOSED 

903
00:34:12,636 --> 00:34:13,270
PATHOBIOLOGY STUDIES USING THE 

904
00:34:13,270 --> 00:34:23,747
EXTENSIVE BIO RECOVER BIO 

905
00:34:23,747 --> 00:34:24,281
REPOSITORY WHICH HAS OVER 

906
00:34:24,281 --> 00:34:24,915
MILLION SAMPLES. SO THERE IS A 

907
00:34:24,915 --> 00:34:25,515
CLINICAL TRIAL IN THE RECOVER 

908
00:34:25,515 --> 00:34:30,687
FRAMEWORK, NOT TLC. 

909
00:34:30,687 --> 00:34:34,724
ONE OF THEM IS, REALLY KNOW, 

910
00:34:34,724 --> 00:34:38,395
RECOVER VITAL, A STUDY LOOKING 

911
00:34:38,395 --> 00:34:42,132
AT VARYING DURATIONS OF ORAL 

912
00:34:42,132 --> 00:34:43,867
PAXLOVID IN PEOPLE WITH COVID 

913
00:34:43,867 --> 00:34:49,840
TO PREVENT LONG COVID.  AND, IT 

914
00:34:49,840 --> 00:34:53,743
IS A PLACEBO-CONTROLLED STUDY.

915
00:34:53,743 --> 00:34:54,311
AND EMBEDDED IN THE TRIAL ARE 

916
00:34:54,311 --> 00:35:00,217
LOTS OF REALLY IMPORTANT 

917
00:35:00,217 --> 00:35:00,851
SURROGATE END POINTS THAT WILL 

918
00:35:00,851 --> 00:35:02,219
HELP US FIGURE OUT WHAT IS 

919
00:35:02,219 --> 00:35:05,589
HAPPENING TO PEOPLE WHEN YOU 

920
00:35:05,589 --> 00:35:06,223
GIVE THEM ANTIVIRAL FOR VARYING 

921
00:35:06,223 --> 00:35:07,524
DEGREES OF TIME. THERE ARE 

922
00:35:07,524 --> 00:35:08,458
PEOPLE IN THE TRIAL WHO DO NOT 

923
00:35:08,458 --> 00:35:13,330
HAVE THE TECHNICAL ANTIGEN 

924
00:35:13,330 --> 00:35:13,964
SARS-COV-2 IN THE BASELINE AND 

925
00:35:13,964 --> 00:35:14,564
SO WE ALSO HAVE A WAY TO LOOK 

926
00:35:14,564 --> 00:35:17,467
AT WHETHER PAXLOVID DID 

927
00:35:17,467 --> 00:35:18,034
ANYTHING IN PEOPLE, EVEN IF 

928
00:35:18,034 --> 00:35:21,238
THEY DIDN'T HAVE VIRUS PRESENT 

929
00:35:21,238 --> 00:35:25,575
IN THE PLASMA AT BASELINE. 

930
00:35:25,575 --> 00:35:28,011
SO IN STUDY THREE SYMPTOM 

931
00:35:28,011 --> 00:35:35,719
COMPLEX THIS IS, NEUROLOGICAL 

932
00:35:35,719 --> 00:35:36,219
DISEASE, CARDIOVASCULAR 

933
00:35:36,219 --> 00:35:36,720
DISEASE, AND I BELIEVE 

934
00:35:36,720 --> 00:35:39,222
FATIGUE-- I COULD BE WRONG. BUT 

935
00:35:39,222 --> 00:35:39,756
CLEARLY DEFINED SYNDROMIC 

936
00:35:39,756 --> 00:35:46,062
GROUPS.  CLEARLY DEFINED 

937
00:35:46,062 --> 00:35:46,630
ENDPOINTS RELATED TO MOSTLY 

938
00:35:46,630 --> 00:35:47,631
IMPROVEMENT, FUNCTIONAL 

939
00:35:47,631 --> 00:35:52,435
IMPROVEMENT. AND PROGRESSION. 

940
00:35:52,435 --> 00:35:53,069
AND THEN THE ABILITY TO LOOK AT 

941
00:35:53,069 --> 00:35:55,639
ANTIGEN THROUGHOUT. 

942
00:35:55,639 --> 00:35:56,139
NOW YOU COULD ASK WHETHER 

943
00:35:56,139 --> 00:35:58,475
PAXLOVID IS THE RIGHT DRUG. 

944
00:35:58,475 --> 00:36:02,379
RIGHT? NOT AN EASY DRUG TO 

945
00:36:02,379 --> 00:36:03,880
TAKE. IF YOU HAVE TAKEN IT, IS 

946
00:36:03,880 --> 00:36:07,417
NOT JUST THE TASTE. BUT IT ALSO 

947
00:36:07,417 --> 00:36:08,051
HAS A LOT OF DRUG INTERACTIONS. 

948
00:36:08,051 --> 00:36:12,088
WE KNOW THAT FROM HIV TREATMENT 

949
00:36:12,088 --> 00:36:12,656
AND WHETHER THIS WILL BE A 

950
00:36:12,656 --> 00:36:16,259
SCALABLE INTERVENTION, I DON'T 

951
00:36:16,259 --> 00:36:20,497
KNOW. BUT I THINK IT HAS TO BE 

952
00:36:20,497 --> 00:36:21,131
STUDY AND WE WILL GET A SIGNAL, 

953
00:36:21,131 --> 00:36:25,268
WHETHER IT IS THE SIGNAL WE 

954
00:36:25,268 --> 00:36:26,169
WANT TO SEE OR NOT WE DON'T 

955
00:36:26,169 --> 00:36:26,503
KNOW.

956
00:36:26,503 --> 00:36:30,574
THE OTHER THING ABOUT 

957
00:36:30,574 --> 00:36:31,207
RECOVER-TLC WE WANT TO DO THIS 

958
00:36:31,207 --> 00:36:34,210
FAST AND ACCURATE, BILLING IT 

959
00:36:34,210 --> 00:36:34,844
ON A MODEL THAT WAS USED IN THE 

960
00:36:34,844 --> 00:36:36,012
PANDEMIC. YOU MAY REMEMBER ACT 

961
00:36:36,012 --> 00:36:40,116
AND ACTIVE, TWO VERSUS 10 NOT 

962
00:36:40,116 --> 00:36:42,218
VERY QUICKLY TREATMENT TRIALS 

963
00:36:42,218 --> 00:36:44,955
FOR COVID AND DONE UNDER -- AND 

964
00:36:44,955 --> 00:36:52,462
THEN WITH ACTIVE A LOT MORE 

965
00:36:52,462 --> 00:36:53,096
INTERVENTIONS WERE INVOLVED, IN 

966
00:36:53,096 --> 00:36:55,298
THIS REPLY FROM TRIALS. SO YOU 

967
00:36:55,298 --> 00:36:57,634
COULD CONTINUE TO USE, AGAIN, 

968
00:36:57,634 --> 00:36:59,302
TOO COMPLICATED TO GO INTO 

969
00:36:59,302 --> 00:37:01,705
THEM, MORE ACCURATE, 

970
00:37:01,705 --> 00:37:04,374
SOPHISTICATED EPIDEMIOLOGICAL 

971
00:37:04,374 --> 00:37:04,908
DISCUSSION ABOUT PLATFORM 

972
00:37:04,908 --> 00:37:06,276
TRIALS.

973
00:37:06,276 --> 00:37:07,444
THE IDEA IS YOU KEEP ON A 

974
00:37:07,444 --> 00:37:12,983
STUDY.  YOU CAN ADD, SUBTRACT, 

975
00:37:12,983 --> 00:37:14,517
COMPARE, COMPARATIVE ARMS; YOU 

976
00:37:14,517 --> 00:37:15,151
ARE MAXIMIZING PARTICIPATION OF 

977
00:37:15,151 --> 00:37:17,220
PARTICIPANTS OVER TIME.  YOU'RE 

978
00:37:17,220 --> 00:37:17,854
NOT STARTING OVER IF YOU DO NOT 

979
00:37:17,854 --> 00:37:22,158
HAVE TO.  YOU CAN ALSO DISCARD 

980
00:37:22,158 --> 00:37:22,759
INTERVENTIONS, AND YOU FIGURE 

981
00:37:22,759 --> 00:37:26,863
OUT EARLY ON, GOING NOWHERE. 

982
00:37:26,863 --> 00:37:27,430
THAT IS IMPORTANT BECAUSE YOU 

983
00:37:27,430 --> 00:37:28,064
DON'T WANT TO HAVE TO BE DOING 

984
00:37:28,064 --> 00:37:35,338
STUDIES IN SERIES. RIGHT? WE 

985
00:37:35,338 --> 00:37:35,939
WANT TO BE DOING THESE THINGS 

986
00:37:35,939 --> 00:37:36,506
IN PARALLEL, SIMILARLY FOR 

987
00:37:36,506 --> 00:37:37,140
INCLUDING PEDIATRICS AND 

988
00:37:37,140 --> 00:37:38,675
STUDIES FOR WOMEN WHO WANT TO 

989
00:37:38,675 --> 00:37:41,011
GET PREGNANT.  WE WANT TO TRY 

990
00:37:41,011 --> 00:37:44,314
TO DO THESE THINGS IN PARALLEL. 

991
00:37:44,314 --> 00:37:44,881
I DO NOT WANT US TO WAIT TO 

992
00:37:44,881 --> 00:37:46,483
STUDY SOMETHING IN WRITING 

993
00:37:46,483 --> 00:37:47,083
WOMEN UNTIL WE TAKE TWO YEARS 

994
00:37:47,083 --> 00:37:57,627
FOR EXAMPLE. TAKE TWO YEARS TO 

995
00:38:00,363 --> 00:38:00,897
SEE IF SOMETHING WORKS NOW WE 

996
00:38:00,897 --> 00:38:01,364
ARE GOING TO STUDY IN 

997
00:38:01,364 --> 00:38:01,998
ADOLESCENCE THAT IS A MISTAKE. 

998
00:38:01,998 --> 00:38:03,033
WE WANT TO MOVE QUICKLY. 

999
00:38:03,033 --> 00:38:07,704
WE WANT TO BE TRANSPARENT.  WE 

1000
00:38:07,704 --> 00:38:08,338
WANT TO HAVE PEOPLE INVOLVED IN 

1001
00:38:08,338 --> 00:38:09,472
THE DECISION-MAKING HERE; MAKE 

1002
00:38:09,472 --> 00:38:10,573
SURE PEOPLE KNOW WHY WE ARE 

1003
00:38:10,573 --> 00:38:14,110
STUDYING CERTAIN THINGS. WHY 

1004
00:38:14,110 --> 00:38:14,711
AREN'T WE STUDYING SOMETHING 

1005
00:38:14,711 --> 00:38:15,879
ELSE THAT SOME PEOPLE HAVE 

1006
00:38:15,879 --> 00:38:16,446
FOUND USEFUL?

1007
00:38:16,446 --> 00:38:18,815
SO TRYING TO PROVIDE ACCESS AND 

1008
00:38:18,815 --> 00:38:19,449
SHARE DATA WITH THE PUBLIC AND 

1009
00:38:19,449 --> 00:38:20,450
THE SCIENTIFIC COMMUNITIES IS 

1010
00:38:20,450 --> 00:38:20,917
GOING TO BE A BEDROCK 

1011
00:38:20,917 --> 00:38:23,720
PRINCIPLE. 

1012
00:38:23,720 --> 00:38:24,254
PATIENT CENTERED CARE WITH 

1013
00:38:24,254 --> 00:38:29,893
PARTNERS -- WE WILL HAVE 

1014
00:38:29,893 --> 00:38:30,393
PATIENTS IN ALL OF OUR 

1015
00:38:30,393 --> 00:38:31,695
COMMITTEES, WE FEEL THAT IS 

1016
00:38:31,695 --> 00:38:32,328
IMPORTANT AND NOT JUST SITTING 

1017
00:38:32,328 --> 00:38:32,929
ON THE COMMITTEE. WE REALLY 

1018
00:38:32,929 --> 00:38:34,330
WANT THEIR PARTICIPATION. WE 

1019
00:38:34,330 --> 00:38:34,931
ARE MODELING THIS THE WAY WE 

1020
00:38:34,931 --> 00:38:38,201
HAVE WORKED WITH OUR HIV-AIDS 

1021
00:38:38,201 --> 00:38:42,672
NETWORK OVER 30 YEARS NOW. 

1022
00:38:42,672 --> 00:38:43,306
WHERE WE CREATED ESSENTIALLY A 

1023
00:38:43,306 --> 00:38:53,817
COMMUNITY OF ADVOCATES.  AND 

1024
00:38:54,350 --> 00:38:54,918
PARTNERS, WHO ALMOST CARRY THE 

1025
00:38:54,918 --> 00:38:56,219
WEIGHT IN TERMS OF EXPLAINING 

1026
00:38:56,219 --> 00:39:06,663
THE STUDIES TO POTENTIAL 

1027
00:39:13,002 --> 00:39:13,536
PARTICIPANTS AND PARTICIPANTS 

1028
00:39:13,536 --> 00:39:14,137
IMPACTED. AND CAN BE PEER OR 

1029
00:39:14,137 --> 00:39:16,406
EDUCATORS IN THE PRESENCE 

1030
00:39:16,406 --> 00:39:17,040
POSSIBLE. PEOPLE WHO THERE ARE 

1031
00:39:17,040 --> 00:39:17,674
NONWHITE IN PARTICULAR ARE MORE 

1032
00:39:17,674 --> 00:39:21,644
LIKELY TO GET LONG COVID.  

1033
00:39:21,644 --> 00:39:22,278
THERE'S A BIG DISPARITY HERE IN 

1034
00:39:22,278 --> 00:39:23,379
TERMS OF WHO IS GETTING SICK. 

1035
00:39:23,379 --> 00:39:25,248
WHO IS BEARING THE BRUNT, NOT 

1036
00:39:25,248 --> 00:39:27,817
JUST THE PHYSICAL STRAIN, BUT 

1037
00:39:27,817 --> 00:39:30,587
THE SOCIOECONOMIC STRAIN? WHO 

1038
00:39:30,587 --> 00:39:32,522
CAN GET ACCESS TO SOPHISTICATED 

1039
00:39:32,522 --> 00:39:33,089
CARE? WHO CAN GET ACCESS TO 

1040
00:39:33,089 --> 00:39:36,760
PARTICIPATING IN RECOVER? LOTS 

1041
00:39:36,760 --> 00:39:37,360
OF STORIES OF PEOPLE DRIVING 

1042
00:39:37,360 --> 00:39:39,462
FOUR HOURS TO THE RECOVERY 

1043
00:39:39,462 --> 00:39:40,063
APPOINTMENT. AND HAVING TO GO 

1044
00:39:40,063 --> 00:39:41,965
THROUGH THE BATTERY OF TESTS, 

1045
00:39:41,965 --> 00:39:42,632
THE QUESTIONNAIRES-- NOT ALWAYS 

1046
00:39:42,632 --> 00:39:44,501
GOOD. 

1047
00:39:44,501 --> 00:39:47,337
I MENTIONED PLATFORM PROTOCOLS. 

1048
00:39:47,337 --> 00:39:47,871
 AND THEN I MENTIONED THE 

1049
00:39:47,871 --> 00:39:50,106
ABILITY TO ADAPT QUICKLY.  SO 

1050
00:39:50,106 --> 00:39:52,442
SOMETHING LOOKS LIKE IT IS NOT 

1051
00:39:52,442 --> 00:39:52,876
WORKING, AND WE CAN 

1052
00:39:52,876 --> 00:39:53,443
SADISTICALLY BE COMFORTABLE 

1053
00:39:53,443 --> 00:39:58,882
WITH THAT. BE COMFORTABLE 

1054
00:39:58,882 --> 00:40:00,784
PHYSIOLOGICALLY. WE THROW IT 

1055
00:40:00,784 --> 00:40:02,051
OUT. WE DO NOT WANT TO WASTE 

1056
00:40:02,051 --> 00:40:02,719
TIME. WE WANT TO HAVE AN ACTIVE 

1057
00:40:02,719 --> 00:40:04,287
PORTFOLIO. 

1058
00:40:04,287 --> 00:40:06,523
WHY ARE WE DOING THIS? BECAUSE 

1059
00:40:06,523 --> 00:40:07,157
THIS HAS BEEN OUR BUSINESS FOR 

1060
00:40:07,157 --> 00:40:10,527
A LONG TIME. RIGHT? WE HAVE 

1061
00:40:10,527 --> 00:40:12,962
DONE VERY LARGE-SCALE, COMPLEX 

1062
00:40:12,962 --> 00:40:13,563
TRIALS PARTICULARLY WHEN YOU 

1063
00:40:13,563 --> 00:40:14,197
THINK ABOUT THE EARLY DAYS OF 

1064
00:40:14,197 --> 00:40:17,133
THE HIV PANDEMIC. THE ONLY 

1065
00:40:17,133 --> 00:40:21,504
THING WE GOT, VERY EARLY ON WAS 

1066
00:40:21,504 --> 00:40:24,607
AZT. THERE WAS A SINGLE FROM 

1067
00:40:24,607 --> 00:40:28,244
AZT THAT HELPED. IMMEDIATELY 

1068
00:40:28,244 --> 00:40:28,812
THAT OPEN THE DOOR TO DRUG 

1069
00:40:28,812 --> 00:40:29,445
DISCOVERY AND MORE IMPORTANTLY 

1070
00:40:29,445 --> 00:40:35,985
TO INDUSTRY BUY-IN, PHARMA 

1071
00:40:35,985 --> 00:40:36,519
BUY-IN, BECAUSE IT WAS A 

1072
00:40:36,519 --> 00:40:40,156
GLIMMER OF HOPE THE DRUGS COULD 

1073
00:40:40,156 --> 00:40:40,757
BE DEVELOPED THAT WOULD HAVE 

1074
00:40:40,757 --> 00:40:41,357
THE POTENTIAL TO PATHWAYS IN 

1075
00:40:41,357 --> 00:40:41,991
THE MARKET AND THAT IS JUST THE 

1076
00:40:41,991 --> 00:40:42,859
REALITY. 

1077
00:40:42,859 --> 00:40:43,426
I AM REALLY HOPEFUL THIS WILL 

1078
00:40:43,426 --> 00:40:49,098
HAPPEN HERE.  WE HAVE DONE A 

1079
00:40:49,098 --> 00:40:49,732
LOT OF STUDIES TO GET PRODUCTS 

1080
00:40:49,732 --> 00:40:50,867
REGULATORY APPROVAL. WE HAVE 

1081
00:40:50,867 --> 00:40:51,434
HAD CONTACTED PARTICIPATION 

1082
00:40:51,434 --> 00:40:57,774
FROM THE FDA YESTERDAY. JOHN 

1083
00:40:57,774 --> 00:41:02,745
FARLEY AND MICHAEL KELLIHIERI 

1084
00:41:02,745 --> 00:41:03,880
(PHONETIC) FROM THE FDA AND 

1085
00:41:03,880 --> 00:41:07,317
THEIR EUROPEAN ASSOCIATE, 

1086
00:41:07,317 --> 00:41:10,119
TALKING WITH THEM WAS CRITICAL. 

1087
00:41:10,119 --> 00:41:10,687
WE HEARD FROM PATIENTS HOW 

1088
00:41:10,687 --> 00:41:14,324
CHALLENGING IT WAS GOING TO BE 

1089
00:41:14,324 --> 00:41:16,693
TO AGREE ON ENDPOINTS THAT THEY 

1090
00:41:16,693 --> 00:41:19,896
FELT WERE FULFILLING CRITERIA 

1091
00:41:19,896 --> 00:41:21,898
FOR APPROVAL. BUT THAT WERE 

1092
00:41:21,898 --> 00:41:24,234
SPECIFIC ENOUGH AND ALSO 

1093
00:41:24,234 --> 00:41:24,834
MEASURABLE ENOUGH TO HOLD UP 

1094
00:41:24,834 --> 00:41:26,836
UNDER REVELATORY SCRUTINY. THAT 

1095
00:41:26,836 --> 00:41:27,403
INTERACTION IS GOING TO BE 

1096
00:41:27,403 --> 00:41:29,772
CRITICAL.  THEY NEED TO BE ON 

1097
00:41:29,772 --> 00:41:33,042
BOARD FROM DAY ZERO. AND SO IT 

1098
00:41:33,042 --> 00:41:34,644
WAS INTERESTING TO HAVE THEM 

1099
00:41:34,644 --> 00:41:35,612
THERE.

1100
00:41:35,612 --> 00:41:37,447
WE HAVE FISCAL SUPPORT. WE HAVE 

1101
00:41:37,447 --> 00:41:37,914
PRIVATE SUPPORT AND 

1102
00:41:37,914 --> 00:41:43,887
REPOSITORIES. EXCELLENT DSMB 

1103
00:41:43,887 --> 00:41:44,454
GIVE ABILITIES AN EXCELLENT 

1104
00:41:44,454 --> 00:41:45,054
BROAD CONTRACT SUPPORT AND I 

1105
00:41:45,054 --> 00:41:46,956
MENTIONED OUR LONG-STANDING 

1106
00:41:46,956 --> 00:41:47,891
RELATIONSHIPS WITH SCIENTIFIC 

1107
00:41:47,891 --> 00:41:48,458
AND ADVOCACY COMMUNITIES 

1108
00:41:48,458 --> 00:41:51,794
PROBABLY HIV/AIDS IS BEST KNOWN 

1109
00:41:51,794 --> 00:41:59,402
FOR THEIR OTHERS. AND WE HAVE 

1110
00:41:59,402 --> 00:41:59,936
PRETTY BIG CLINICAL TRIAL 

1111
00:41:59,936 --> 00:42:00,570
SHOPS, ACROSS MEDICAL OFFICERS 

1112
00:42:00,570 --> 00:42:01,070
AND PROGRAMS AS YOU CAN 

1113
00:42:01,070 --> 00:42:02,672
IMAGINE. 

1114
00:42:02,672 --> 00:42:03,273
REALLY BRIEFLY IN THE LAST FIVE 

1115
00:42:03,273 --> 00:42:05,308
MINUTES I WILL SAY THE IDEA 

1116
00:42:05,308 --> 00:42:06,142
HERE IS TO DO A REALLY DEEP 

1117
00:42:06,142 --> 00:42:09,012
DIVE ON WHAT THE CURRENT 

1118
00:42:09,012 --> 00:42:09,512
RECOVER CLINICAL TRIALS 

1119
00:42:09,512 --> 00:42:11,781
LANDSCAPE IS. WHAT IS BEING 

1120
00:42:11,781 --> 00:42:15,985
DONE? WE KNOW THERE ARE FOUR 

1121
00:42:15,985 --> 00:42:19,389
TRIALS AND MORE PLANNED. WHAT 

1122
00:42:19,389 --> 00:42:19,989
CAN WE LEARN FROM THE DESIGN 

1123
00:42:19,989 --> 00:42:21,190
AND CONDUCT OF THE STUDIES? 

1124
00:42:21,190 --> 00:42:21,724
THAT WILL DETERMINE WHAT 

1125
00:42:21,724 --> 00:42:23,660
MODIFICATIONS ARE NEEDED. AND 

1126
00:42:23,660 --> 00:42:26,863
IF YOU THINK ABOUT TRIAL 

1127
00:42:26,863 --> 00:42:27,497
ENDPOINT, THE ABILITY TO REACH 

1128
00:42:27,497 --> 00:42:32,201
ENROLLMENT TARGETS, SITES 

1129
00:42:32,201 --> 00:42:32,735
PARTICIPATING IN WE WANT 

1130
00:42:32,735 --> 00:42:33,336
RECOVERY SITE TO PARTICIPATE. 

1131
00:42:33,336 --> 00:42:40,376
BUT IF WE NEED TO GO BEYOND TO 

1132
00:42:40,376 --> 00:42:40,944
OTHER NETWORK WE WILL GO TO 

1133
00:42:40,944 --> 00:42:43,279
OTHER NETWORKS THAT CAN ENROLL 

1134
00:42:43,279 --> 00:42:43,746
THE MOST APPROPRIATE 

1135
00:42:43,746 --> 00:42:46,149
PARTICIPANTS. BOTTOM LINE. 

1136
00:42:46,149 --> 00:42:46,649
WE NEED TO FIGURE OUT OUR 

1137
00:42:46,649 --> 00:42:49,185
BUDGET AND WE ARE WORKING ON 

1138
00:42:49,185 --> 00:42:49,819
THAT. AND IF I LESSONS LEARNED 

1139
00:42:49,819 --> 00:42:50,820
FROM PROTOCOL DESIGN AND LAUNCH 

1140
00:42:50,820 --> 00:42:51,387
OF THE NEW CLINICAL TRIALS 

1141
00:42:51,387 --> 00:42:53,790
PROGRAM. 

1142
00:42:53,790 --> 00:42:55,224
WE ARE ALREADY PLANNING ON 

1143
00:42:55,224 --> 00:42:56,559
HAVING PERIODIC MEETINGS AS A 

1144
00:42:56,559 --> 00:42:59,929
FOLLOW-UP TO THE 2 1/2 DAY 

1145
00:42:59,929 --> 00:43:01,998
MEETING WE JUST HAD. THE 

1146
00:43:01,998 --> 00:43:02,598
MEETING WAS REALLY I THOUGHT 

1147
00:43:02,598 --> 00:43:07,603
VERY GOOD; RAISED AS MANY 

1148
00:43:07,603 --> 00:43:10,807
CHALLENGES AS POTENTIAL 

1149
00:43:10,807 --> 00:43:11,441
SOLUTIONS. BUT WHAT WE DID THE 

1150
00:43:11,441 --> 00:43:12,041
MEETING WAS REALLY TO DISCUSS 

1151
00:43:12,041 --> 00:43:13,476
WHERE WE ARE AT IN OUR 

1152
00:43:13,476 --> 00:43:14,110
UNDERSTANDING OF THE RESEARCH, 

1153
00:43:14,110 --> 00:43:15,511
AND CLINICAL NATURE OF LONG 

1154
00:43:15,511 --> 00:43:18,081
COVID. 

1155
00:43:18,081 --> 00:43:20,516
SO STATE OF THE SCIENCE. AND 

1156
00:43:20,516 --> 00:43:22,986
TALK ABOUT HOW DO WE MOVE THIS 

1157
00:43:22,986 --> 00:43:23,619
FORWARD. WE WILL HAVE PERIODIC 

1158
00:43:23,619 --> 00:43:29,392
WEBINARS TO SHARE WHAT WE ARE 

1159
00:43:29,392 --> 00:43:30,026
DOING WITH SCIENTIFIC CLINICAL 

1160
00:43:30,026 --> 00:43:33,029
AND PATIENT COMMUNITIES, AND 

1161
00:43:33,029 --> 00:43:33,663
IMPORTANTLY WILL HAVE AN ANNUAL 

1162
00:43:33,663 --> 00:43:34,230
MEETING NEXT YEAR HOPEFULLY 

1163
00:43:34,230 --> 00:43:42,939
SOMEPLACE BIGGER, THAN THIS 

1164
00:43:42,939 --> 00:43:43,573
TIME PLANNED FOR FIVE WEEKS. SO 

1165
00:43:43,573 --> 00:43:44,207
IT WAS REALLY, REALLY FAST. THE 

1166
00:43:44,207 --> 00:43:46,876
TEAMWORK REALLY REALLY HARD.

1167
00:43:46,876 --> 00:43:47,343
I WANT TO EMPHASIZE THE 

1168
00:43:47,343 --> 00:43:48,277
ENGAGEMENT. THAT IS CORE OF 

1169
00:43:48,277 --> 00:43:53,383
WHERE WE ARE AT AT NIAID. THIS 

1170
00:43:53,383 --> 00:43:54,017
IS NOT JUST A MATTER OF HAVING 

1171
00:43:54,017 --> 00:43:55,685
A PATIENT REPRESENTATIVE. THIS 

1172
00:43:55,685 --> 00:44:03,926
IS A MATTER OF HAVING PEOPLE 

1173
00:44:03,926 --> 00:44:04,627
INVOLVED IN PROTOCOL DESIGN, 

1174
00:44:04,627 --> 00:44:07,764
PROTOCOL REVIEW. PRESENTING THE 

1175
00:44:07,764 --> 00:44:14,003
PROTOCOL TO COMMUNITIES AND 

1176
00:44:14,003 --> 00:44:15,571
GETTING BUY-IN, ASSESSMENT AND 

1177
00:44:15,571 --> 00:44:16,172
MEANINGFUL CONTRIBUTION IS A 

1178
00:44:16,172 --> 00:44:16,739
REALLY GOOD EXAMPLE OF WHAT 

1179
00:44:16,739 --> 00:44:18,841
HAPPENS WHEN YOU DON'T DO THAT. 

1180
00:44:18,841 --> 00:44:19,409
YOU DESIGN THE PROTOCOL AND I 

1181
00:44:19,409 --> 00:44:20,610
HAVE BEEN GUILTY OF THIS 

1182
00:44:20,610 --> 00:44:22,912
MYSELF-- AND NOT AT ALL PERFECT 

1183
00:44:22,912 --> 00:44:24,781
IN THIS ROUND-- YOU DESIGN ARE 

1184
00:44:24,781 --> 00:44:25,415
ALL THINKING YOU KNOW WHAT THE 

1185
00:44:25,415 --> 00:44:28,418
DISEASE LOOKS LIKE AND WHAT IT 

1186
00:44:28,418 --> 00:44:29,018
IS. YOU DON'T HAVE IT, MAYBE 

1187
00:44:29,018 --> 00:44:30,153
AND THEN IT TURNS OUT YOU 

1188
00:44:30,153 --> 00:44:32,488
REALLY WISH YOU HAD TALKED TO 

1189
00:44:32,488 --> 00:44:34,657
MORE PEOPLE BEFORE YOU DID WHAT 

1190
00:44:34,657 --> 00:44:43,966
WE DID. AND WE WILL HAVE A 

1191
00:44:43,966 --> 00:44:44,534
COMMUNITY ENGAGEMENT GROUP, 

1192
00:44:44,534 --> 00:44:46,736
THIS IS IN FLUX, I DON'T WANT 

1193
00:44:46,736 --> 00:44:50,740
TO BE TOO SPECIFIC BUT WILL 

1194
00:44:50,740 --> 00:44:51,340
HAVE THE COMMUNITY ENGAGED IN 

1195
00:44:51,340 --> 00:44:51,874
ALL WORKING GROUPS IN THE 

1196
00:44:51,874 --> 00:44:53,209
SCIENTIFIC COMMUNITY. 

1197
00:44:53,209 --> 00:44:54,544
I THINK I'VE SAID MOST OF THIS. 

1198
00:44:54,544 --> 00:44:55,111
ONE THING I WILL MENTION IS 

1199
00:44:55,111 --> 00:44:57,713
THAT, TWO THINGS. ONE WE DO NOT 

1200
00:44:57,713 --> 00:44:59,882
WANT TO RE-CREATE THE BIO 

1201
00:44:59,882 --> 00:45:03,886
REPOSITORY THAT RECOVER HAS. IF 

1202
00:45:03,886 --> 00:45:07,290
WE DO BIO SPECIMENS THAT WILL 

1203
00:45:07,290 --> 00:45:07,890
BE SPECIFICALLY LINKED TO THE 

1204
00:45:07,890 --> 00:45:11,227
PURPOSE OF THE TRIAL. IT WILL 

1205
00:45:11,227 --> 00:45:11,928
BE A NEW VIRAL DEPOSITORY I 

1206
00:45:11,928 --> 00:45:13,963
THINK MADE AVAILABLE TO OUTSIDE 

1207
00:45:13,963 --> 00:45:19,001
AND INSIDE RESEARCHERS. AND WE 

1208
00:45:19,001 --> 00:45:19,602
WILL LINK ALL OF THAT TO THE 

1209
00:45:19,602 --> 00:45:20,236
CLINICAL DATA, AS WE HAVE DONE 

1210
00:45:20,236 --> 00:45:22,338
FOR OUR OTHER STUDIES. 

1211
00:45:22,338 --> 00:45:22,939
THE OTHER IMPORTANT PART ABOUT 

1212
00:45:22,939 --> 00:45:26,008
TRIAL DESIGNS IS, YOU WANT TO 

1213
00:45:26,008 --> 00:45:26,576
DO LARGE TRIALS TO LOOK FOR 

1214
00:45:26,576 --> 00:45:28,811
EFFICACY OF COURSE. BUT WE HAVE 

1215
00:45:28,811 --> 00:45:30,346
THOSE YET? DO WE HAVE AGENTS 

1216
00:45:30,346 --> 00:45:34,650
THAT WE CAN SAY, WE WANT TO DO 

1217
00:45:34,650 --> 00:45:36,352
A 2000 PERSON TRIAL? NOT SO 

1218
00:45:36,352 --> 00:45:38,154
SURE. WE WILL BE DOING A DEEP 

1219
00:45:38,154 --> 00:45:44,293
ASSESSMENT OF THE LANDSCAPE. 

1220
00:45:44,293 --> 00:45:44,927
BUT WE MAY START WITH VERY SOON 

1221
00:45:44,927 --> 00:45:47,430
I WOULD SAY SMALLER MECHANISM 

1222
00:45:47,430 --> 00:45:48,030
STUDIES WHERE WE CAN LOOK AT 

1223
00:45:48,030 --> 00:45:49,699
HYPOTHESES DRIVEN BY SOME OF 

1224
00:45:49,699 --> 00:45:52,135
THE PATHOBIOLOGY, AND 

1225
00:45:52,135 --> 00:45:56,906
INCORPORATE BIOMARKERS AND 

1226
00:45:56,906 --> 00:45:57,473
MEASURES OF WHETHER WE ARE 

1227
00:45:57,473 --> 00:45:58,441
MAKING AN IMPACT WITH WHATEVER 

1228
00:45:58,441 --> 00:45:59,008
INNOVATIONS WE ARE TALKING 

1229
00:45:59,008 --> 00:46:00,676
ABOUT. 

1230
00:46:00,676 --> 00:46:01,277
I SUSPECT WILL START WITH SOME 

1231
00:46:01,277 --> 00:46:02,745
OF THOSE. BUT AGAIN THESE ARE 

1232
00:46:02,745 --> 00:46:05,081
ALL OF THE DISCUSSION. 

1233
00:46:05,081 --> 00:46:07,884
THIS WAS OUR ORIGINAL TAKE IN 

1234
00:46:07,884 --> 00:46:10,586
THE ORGANIZATION. I DO WANT TO 

1235
00:46:10,586 --> 00:46:12,755
DWELL ON THIS BECAUSE AFTER THE 

1236
00:46:12,755 --> 00:46:13,389
MEETING WE ARE GOING TO CHANGE 

1237
00:46:13,389 --> 00:46:15,358
IT UP QUITE A LOT.  BUT THE 

1238
00:46:15,358 --> 00:46:18,694
IDEA IS THAT WE HAVE A 

1239
00:46:18,694 --> 00:46:19,328
SCIENTIFIC OVERSIGHT COMMUNITY, 

1240
00:46:19,328 --> 00:46:20,496
THAT REALLY DIRECTS THE 

1241
00:46:20,496 --> 00:46:22,899
SCIENCE. AND THAT IS FED BY 

1242
00:46:22,899 --> 00:46:23,399
WORKING GROUPS THAT ARE 

1243
00:46:23,399 --> 00:46:29,572
PROBABLY RELATED TO THINGS LIKE 

1244
00:46:29,572 --> 00:46:30,106
NEURO MANIFESTATIONS AND 

1245
00:46:30,106 --> 00:46:32,175
PATHOLOGY, VASTLY DISEASE AND 

1246
00:46:32,175 --> 00:46:36,312
VIROLOGY.  IMPORTANT ALSO GROUP 

1247
00:46:36,312 --> 00:46:36,946
THAT OVERSEES OPERATIONS, A LOT 

1248
00:46:36,946 --> 00:46:38,514
OF INTERACTION BETWEEN THOSE 

1249
00:46:38,514 --> 00:46:41,117
GROUPS. 

1250
00:46:41,117 --> 00:46:44,954
AND VERY IMPORTANTLY, A PORTAL, 

1251
00:46:44,954 --> 00:46:49,158
AN OPEN WAY FOR INDUSTRY AND 

1252
00:46:49,158 --> 00:46:50,760
ANYONE TO SUBMIT INTERVENTION 

1253
00:46:50,760 --> 00:46:51,360
CANDIDATES. SO WE DEBUTED, OR 

1254
00:46:51,360 --> 00:46:52,728
PREVIEWED I SHOULD SAY, THE 

1255
00:46:52,728 --> 00:46:53,596
PORTAL CANDIDATE, SIMILAR TO 

1256
00:46:53,596 --> 00:46:57,800
WHAT WAS USED IN THE ACT TRIALS 

1257
00:46:57,800 --> 00:47:00,336
WHERE ANYBODY COULD GO IN AND 

1258
00:47:00,336 --> 00:47:03,339
PROPOSE AN INTERVENTION-- 

1259
00:47:03,339 --> 00:47:07,743
WHETHER IT'S AN AGENT OR A 

1260
00:47:07,743 --> 00:47:08,110
DEVICE.

1261
00:47:08,110 --> 00:47:11,614
AND THAT WILL BE OUR MAIN WAY 

1262
00:47:11,614 --> 00:47:13,916
FOR PEOPLE TO GET INTO THIS. 

1263
00:47:13,916 --> 00:47:15,251
OF COURSE WE ALSO WELCOME 

1264
00:47:15,251 --> 00:47:18,054
DIRECT CONTACT FROM INDUSTRY.  

1265
00:47:18,054 --> 00:47:18,688
THERE WERE A NUMBER OF INDUSTRY 

1266
00:47:18,688 --> 00:47:19,922
FOLKS AT THE MEETING; THAT 

1267
00:47:19,922 --> 00:47:22,758
ACTUALLY WAS QUITE HELPFUL. 

1268
00:47:22,758 --> 00:47:24,427
SO JUST AS LAST SLIDE TO 

1269
00:47:24,427 --> 00:47:28,664
SUMMARIZE A COUPLE OF OTHER 

1270
00:47:28,664 --> 00:47:29,298
THOUGHTS ABOUT THE WORKSHOP AND 

1271
00:47:29,298 --> 00:47:29,899
I ACTUALLY GOT A WHOLE SERIES 

1272
00:47:29,899 --> 00:47:31,200
OF SLIDES I USED YESTERDAY TO 

1273
00:47:31,200 --> 00:47:33,035
WRAP IT UP. BUT I CAN TALK MORE 

1274
00:47:33,035 --> 00:47:37,740
ABOUT THOSE IF YOU WANT. BUT TO 

1275
00:47:37,740 --> 00:47:38,307
GIVE YOU A QUICK SENSE, WE 

1276
00:47:38,307 --> 00:47:39,675
FILLED THE ROOM. WE COULD NOT 

1277
00:47:39,675 --> 00:47:42,979
GET A BIGGER ROOM IN TIME. SO 

1278
00:47:42,979 --> 00:47:46,515
WE HAD OUR MAX OF 180 PEOPLE, 

1279
00:47:46,515 --> 00:47:47,149
THERE WERE 1200 PEOPLE ONLINE; 

1280
00:47:47,149 --> 00:47:47,683
WE INTENTIONALLY BROUGHT 

1281
00:47:47,683 --> 00:47:50,419
TOGETHER PEOPLE FROM RECOVER 

1282
00:47:50,419 --> 00:47:56,892
PATIENTS OUT OF THE KITS, AND 

1283
00:47:56,892 --> 00:48:00,463
RESEARCHERS IN HOPEFULLY 

1284
00:48:00,463 --> 00:48:01,030
EXAMPLE WAS REPORTED IN MY 

1285
00:48:01,030 --> 00:48:05,067
COMFORTABLE LAST 45 MINUTES. 

1286
00:48:05,067 --> 00:48:05,635
PATIENTS HAVE TO BE INVOLVED 

1287
00:48:05,635 --> 00:48:07,870
FROM THE GET-GO AND IN THE 

1288
00:48:07,870 --> 00:48:08,504
ONGOING FIGHT, SO WE CAN BE 

1289
00:48:08,504 --> 00:48:09,138
CAMPING FOR WHAT WE ARE DOING. 

1290
00:48:09,138 --> 00:48:10,773
THAT IS THE ONLY WAY WE'RE 

1291
00:48:10,773 --> 00:48:11,507
GOING TO GET TRUST WITH THE 

1292
00:48:11,507 --> 00:48:12,074
COMMUNITY AND GET PEOPLE TO 

1293
00:48:12,074 --> 00:48:14,543
PARTICIPATE. 

1294
00:48:14,543 --> 00:48:17,913
WE REALLY NEED TO ESCALATE 

1295
00:48:17,913 --> 00:48:18,481
URGENCY FOR INFORMED TRIAL 

1296
00:48:18,481 --> 00:48:19,181
DESIGN USING THE EXISTING BIO 

1297
00:48:19,181 --> 00:48:21,384
SAMPLES. RIGHT? SO THERE IS A 

1298
00:48:21,384 --> 00:48:25,388
VERY BIG REPOSITORY THAT COULD 

1299
00:48:25,388 --> 00:48:27,523
BE LEVERAGED VERY QUICKLY TO 

1300
00:48:27,523 --> 00:48:30,559
START LOOKING AT BIOMARKERS. 

1301
00:48:30,559 --> 00:48:31,160
AND I THINK THAT IS SOMETHING 

1302
00:48:31,160 --> 00:48:31,894
THAT NEEDS TO HAPPEN VERY, VERY 

1303
00:48:31,894 --> 00:48:36,232
SOON.  BECAUSE WE NEED THAT TO 

1304
00:48:36,232 --> 00:48:37,700
TAKE A LOOK AT THESE DISTINCT 

1305
00:48:37,700 --> 00:48:42,905
PHENOTYPES, BIO TYPES, AND 

1306
00:48:42,905 --> 00:48:43,506
THINK ABOUT HOW YOU ARE GOING 

1307
00:48:43,506 --> 00:48:44,073
TO DESIGN STUDIES, BOTH FOR 

1308
00:48:44,073 --> 00:48:44,640
PATHOBIOLOGY AND ALSO FOR 

1309
00:48:44,640 --> 00:48:48,311
INTERVENTIONS. 

1310
00:48:48,311 --> 00:48:48,844
MANY PEOPLE IN THE AUDIENCE 

1311
00:48:48,844 --> 00:48:49,478
THOUGHT THAT WE WOULD PROBABLY 

1312
00:48:49,478 --> 00:48:51,414
ULTIMATELY NEED MULTICOMPONENT 

1313
00:48:51,414 --> 00:48:55,151
INTERVENTIONS. SO ANTIVIRALS, 

1314
00:48:55,151 --> 00:49:01,557
ANTI-INFLAMMATORY, -- 

1315
00:49:01,557 --> 00:49:02,058
MODULATORS, YOU NAME IT 

1316
00:49:02,058 --> 00:49:02,625
METABOLIC ALTERING DRUGS. I 

1317
00:49:02,625 --> 00:49:05,261
THINK LIKE WE DESIGNED MANY OF 

1318
00:49:05,261 --> 00:49:07,730
THE HIV THERAPEUTIC TRIALS.  WE 

1319
00:49:07,730 --> 00:49:13,369
HAD COMBINATIONS THAT WERE 

1320
00:49:13,369 --> 00:49:13,969
GOOD; AND WE GOT NOMINATIONS 

1321
00:49:13,969 --> 00:49:14,437
THAT WERE BETTER, AND 

1322
00:49:14,437 --> 00:49:14,970
INDIVIDUAL AGES THAT WERE 

1323
00:49:14,970 --> 00:49:15,571
BETTER, AND DELIVERY SYSTEMS 

1324
00:49:15,571 --> 00:49:17,740
THAT WERE BETTER.  SO THINKING 

1325
00:49:17,740 --> 00:49:21,777
ABOUT HOW YOU DESIGN TRIALS TO 

1326
00:49:21,777 --> 00:49:22,945
START ADVANCING COMPLEX-- 

1327
00:49:22,945 --> 00:49:23,979
SOMETIMES MULTI-MECHANISTIC 

1328
00:49:23,979 --> 00:49:24,580
REGIMENTS I THINK IS GOING TO 

1329
00:49:24,580 --> 00:49:25,948
BE REALLY IMPORTANT. 

1330
00:49:25,948 --> 00:49:29,985
AND THEN THE LAST THING IS, I 

1331
00:49:29,985 --> 00:49:30,519
THINK YOU KNOW INFECTION 

1332
00:49:30,519 --> 00:49:32,421
ASSOCIATED CHRONIC WORK 

1333
00:49:32,421 --> 00:49:33,022
CONDITIONS IS A BIG AREA THAT 

1334
00:49:33,022 --> 00:49:34,824
WE JUST HAVE TO EMBRACE. YOU 

1335
00:49:34,824 --> 00:49:39,895
KNOW? NOT JUST AT THE NIH BUT I 

1336
00:49:39,895 --> 00:49:40,496
PROCESS IT IS BECAUSE YOU SAW 

1337
00:49:40,496 --> 00:49:43,632
ALL THE ORGAN SYSTEMS AFFECTED 

1338
00:49:43,632 --> 00:49:44,266
AND ALL THE PATHWAYS THAT MIGHT 

1339
00:49:44,266 --> 00:49:47,870
BE INVOLVED.  YOU SAW THE FACT 

1340
00:49:47,870 --> 00:49:50,906
THAT MINORITY POPULATIONS-- IF 

1341
00:49:50,906 --> 00:49:51,507
YOU WANT TO USE THAT TERM OR 

1342
00:49:51,507 --> 00:49:52,141
UNDERREPRESENTED MINORITIES-- 

1343
00:49:52,141 --> 00:49:57,680
ARE MORE AFFECTED. I MEAN 

1344
00:49:57,680 --> 00:49:58,314
THERE'S ALMOST NOT AN INSTITUTE 

1345
00:49:58,314 --> 00:49:58,914
HERE THAT IS NOT POTENTIALLY 

1346
00:49:58,914 --> 00:50:02,918
AFFECTED BY LONG COVID. 

1347
00:50:02,918 --> 00:50:05,254
I THINK THAT IS MY LAST SLIDE. 

1348
00:50:05,254 --> 00:50:06,589
I'M GOING TO STOP THERE AND 

1349
00:50:06,589 --> 00:50:10,726
STOP SHARING. AND LEFT 10 

1350
00:50:10,726 --> 00:50:11,293
MINUTES. SORRY I WANTED TO 

1351
00:50:11,293 --> 00:50:11,861
LEAVE MORE, BUT ENDED GOING 

1352
00:50:11,861 --> 00:50:13,662
LONGER. SORRY. 

1353
00:50:13,662 --> 00:50:17,500
I'M GOING TO HAND IT OVER TO 

1354
00:50:17,500 --> 00:50:19,168
VERONIQUE WHO WILL MODERATE. 

1355
00:50:19,168 --> 00:50:23,539
>> THANK YOU DR. MARRAZZO.
I AM 

1356
00:50:23,539 --> 00:50:25,841
AN INFECTIOUS CLINICIAN STAFF 

1357
00:50:25,841 --> 00:50:27,676
AT NIAID AND I WILL RELAY YOUR 

1358
00:50:27,676 --> 00:50:29,745
QUESTIONS TO DR. MARRAZZO.  

1359
00:50:29,745 --> 00:50:31,881
THIS AFTERNOON I WILL REMIND 

1360
00:50:31,881 --> 00:50:36,018
EVERYBODY TO USE THE "SAND LIVE 

1361
00:50:36,018 --> 00:50:36,619
FEEDBACK" BUTTON ON THE VIDEO 

1362
00:50:36,619 --> 00:50:37,219
CASCADE TO SEND QUESTIONS TO 

1363
00:50:37,219 --> 00:50:40,356
DR. MARRAZZO. 

1364
00:50:40,356 --> 00:50:40,956
DR. MARRAZZO THANK YOU SO MUCH 

1365
00:50:40,956 --> 00:50:42,191
TALK TODAY, IT IS REALLY 

1366
00:50:42,191 --> 00:50:42,758
WONDERFUL TO SEE EVERYTHING 

1367
00:50:42,758 --> 00:50:46,061
THAT IS DONE.  ALL THIS 

1368
00:50:46,061 --> 00:50:46,662
WONDERFUL WORK AND INITIATIVE 

1369
00:50:46,662 --> 00:50:48,030
TO LEARN ABOUT, AND TO 

1370
00:50:48,030 --> 00:50:52,768
HOPEFULLY TREAT LONG COVID, 

1371
00:50:52,768 --> 00:50:53,302
WHICH IS A CONDITION THAT 

1372
00:50:53,302 --> 00:50:53,903
AFFECTS SO MANY PEOPLE AROUND 

1373
00:50:53,903 --> 00:50:55,337
THE WORLD. 

1374
00:50:55,337 --> 00:50:55,905
SO WE HAVE SEVERAL QUESTIONS 

1375
00:50:55,905 --> 00:50:57,473
COMING IN. THE FIRST QUESTION 

1376
00:50:57,473 --> 00:50:59,275
FOR YOU IS, WHICH INSTITUTE AT 

1377
00:50:59,275 --> 00:51:02,144
THE NIH LEADING THE EFFORTS TO 

1378
00:51:02,144 --> 00:51:04,313
FIND THERAPIES FOR LONG COVID?

1379
00:51:04,313 --> 00:51:08,017
>> DR. MARRAZZO: GREAT 

1380
00:51:08,017 --> 00:51:08,584
QUESTION. I THINK IT IS US 

1381
00:51:08,584 --> 00:51:12,655
RIGHT NOW.  BECAUSE WE ARE 

1382
00:51:12,655 --> 00:51:14,924
TASKED FOR ALL THE REASONS THAT 

1383
00:51:14,924 --> 00:51:15,491
I MENTIONED, FOR TRYING TO 

1384
00:51:15,491 --> 00:51:17,226
STAND UP CLINICAL TRIALS. 

1385
00:51:17,226 --> 00:51:17,793
AND SO IT IS NOT TO SAY THAT 

1386
00:51:17,793 --> 00:51:24,433
OTHER ... INSTITUTES AREN'T IN 

1387
00:51:24,433 --> 00:51:27,870
THE DRUG DEVELOPMENT BUSINESS, 

1388
00:51:27,870 --> 00:51:28,370
IT MAY TURN OUT THAT A 

1389
00:51:28,370 --> 00:51:29,772
CARDIOVASCULAR DRUG MIGHT BE A 

1390
00:51:29,772 --> 00:51:32,141
HUGE WIN IN SOME MANIFESTATIONS 

1391
00:51:32,141 --> 00:51:35,010
OF LONG COVID. AND MAYBE EVEN 

1392
00:51:35,010 --> 00:51:36,278
IN PREVENTION.

1393
00:51:36,278 --> 00:51:36,812
SO I WOULD SAY WE ARE ALL 

1394
00:51:36,812 --> 00:51:40,216
INVOLVED.  THE POINT IS FOR US 

1395
00:51:40,216 --> 00:51:46,155
TO TAKE-- TO PROVIDE SORT OF A 

1396
00:51:46,155 --> 00:51:46,789
FUNNELED, DIRECT PATHWAY SO IT 

1397
00:51:46,789 --> 00:51:49,658
IS NOT CONFUSING. SO IF YOU 

1398
00:51:49,658 --> 00:51:51,827
HAVE A DRUG THAT YOU'RE 

1399
00:51:51,827 --> 00:51:52,394
INTERESTED IN, OR YOU KNOW 

1400
00:51:52,394 --> 00:51:52,995
SOMEBODY WHO HAS A DRUG, COME 

1401
00:51:52,995 --> 00:51:55,731
TO US. COME TO THE PORTAL THAT 

1402
00:51:55,731 --> 00:51:56,298
WE WILL HAVE PROBABLY AFTER 

1403
00:51:56,298 --> 00:51:57,833
NEXT WEEK OR SO AND WE CAN 

1404
00:51:57,833 --> 00:51:58,501
FACILITATE WHAT THAT MIGHT LOOK 

1405
00:51:58,501 --> 00:51:58,834
LIKE. 

1406
00:51:58,834 --> 00:52:02,271
I WILL SAY TOO, A LOT OF PEOPLE 

1407
00:52:02,271 --> 00:52:05,341
ASKED AT THE MEETING, WELL ARE 

1408
00:52:05,341 --> 00:52:05,975
YOU DEVELOPING ANTIVIRAL DRUGS 

1409
00:52:05,975 --> 00:52:07,309
THAT YOU THINK MIGHT WORK 

1410
00:52:07,309 --> 00:52:11,881
BETTER THAN PAXLOVID? AND THE 

1411
00:52:11,881 --> 00:52:20,823
ANSWER IS YEAH, WE HAVE 

1412
00:52:20,823 --> 00:52:21,357
ANTIVIRAL DRUG DISCOVERY 

1413
00:52:21,357 --> 00:52:21,891
PROGRAM, AND WITH ALL THE 

1414
00:52:21,891 --> 00:52:22,825
INFLUENZA STUFF GOING ON, THERE 

1415
00:52:22,825 --> 00:52:24,260
VERY INTERESTED IN RESPIRATORY 

1416
00:52:24,260 --> 00:52:25,394
VIRUSES BUT MOST OF THOSE 

1417
00:52:25,394 --> 00:52:31,200
PRODUCTS ARE IN THE EARLY PHASE 

1418
00:52:31,200 --> 00:52:31,800
DEVELOPMENT. THERE IS NOTHING 

1419
00:52:31,800 --> 00:52:32,434
WE CAN PLUCK OUT AND SAY LET'S 

1420
00:52:32,434 --> 00:52:36,872
LOOK AT THIS FOR LONG COVID. SO 

1421
00:52:36,872 --> 00:52:39,475
FOR IMMUNOLOGICS IT COULD BE 

1422
00:52:39,475 --> 00:52:40,109
ANY OF THESE INTRODUCE THE DEAL 

1423
00:52:40,109 --> 00:52:42,711
WITH SPECIFIC MANIFESTATIONS. 

1424
00:52:42,711 --> 00:52:43,178
>> GRADE WE HAD ANOTHER 

1425
00:52:43,178 --> 00:52:43,746
QUESTION SPECIFICALLY ALONG 

1426
00:52:43,746 --> 00:52:46,549
THOSE LINES.  OF THE ONE HAS A 

1427
00:52:46,549 --> 00:52:47,716
NOVEL DRUG THAT WE THINK MIGHT 

1428
00:52:47,716 --> 00:52:51,620
BE EFFECTIVE FOR TREATING LONG 

1429
00:52:51,620 --> 00:52:52,187
COVID, HOW DOES ONE GET IN 

1430
00:52:52,187 --> 00:52:57,493
TOUCH WITH NIAID? HOW DO WE 

1431
00:52:57,493 --> 00:53:00,062
FIND OUT? SOUNDS LIKE THERE 

1432
00:53:00,062 --> 00:53:00,563
WILL BE A PORTAL MADE 

1433
00:53:00,563 --> 00:53:01,263
AVAILABLE. 

1434
00:53:01,263 --> 00:53:04,333
>> DR. MARRAZZO: THEY WILL
BE A 

1435
00:53:04,333 --> 00:53:04,934
PORTAL AND YOU ARE WELCOME TO 

1436
00:53:04,934 --> 00:53:08,737
CONTACT ANY OF US.  ONE OF THE 

1437
00:53:08,737 --> 00:53:09,338
THINGS I COMMITTED TO AT THE 

1438
00:53:09,338 --> 00:53:09,905
MEETING WAS ESTABLISHING AN 

1439
00:53:09,905 --> 00:53:12,675
OFFICE WITHIN MY GROUP.  SO IT 

1440
00:53:12,675 --> 00:53:13,242
IS NOT A FORMAL INSTITUTE, 

1441
00:53:13,242 --> 00:53:15,844
NOTHING LIKE THAT.  BUT I WILL 

1442
00:53:15,844 --> 00:53:17,446
HAVE SOMEONE OVERSEEING THESE 

1443
00:53:17,446 --> 00:53:18,047
EFFORTS DIRECTLY REPORTING TO 

1444
00:53:18,047 --> 00:53:20,349
ME IN MY OFFICE. AND WE ARE 

1445
00:53:20,349 --> 00:53:21,584
WORKING ON THAT, AND THE 

1446
00:53:21,584 --> 00:53:24,653
LOGISTICS ON THAT. 

1447
00:53:24,653 --> 00:53:26,088
AND I REALLY WANT THIS TO BE 

1448
00:53:26,088 --> 00:53:28,958
SEAMLESS; I WANT IT TO BE KIND 

1449
00:53:28,958 --> 00:53:32,127
OF A PRIORITY FOR OUR OFFICE.  

1450
00:53:32,127 --> 00:53:36,098
AND I THINK THAT ANY OUTREACH 

1451
00:53:36,098 --> 00:53:37,466
TO US WILL OBVIOUSLY BE TAKEN 

1452
00:53:37,466 --> 00:53:40,169
SERIOUSLY. 

1453
00:53:40,169 --> 00:53:44,540
I WOULD ALSO SAY IF YOU'RE 

1454
00:53:44,540 --> 00:53:45,174
INTERESTED BE SURE TO KEEP YOUR 

1455
00:53:45,174 --> 00:53:47,610
EYES OUT. WE WILL DISSEMINATE 

1456
00:53:47,610 --> 00:53:48,243
WIDELY REPORTED MEETING WHICH I 

1457
00:53:48,243 --> 00:53:48,844
HOPE WILL BE DONE IN A COUPLE 

1458
00:53:48,844 --> 00:53:49,478
OF WEEKS. 

1459
00:53:49,478 --> 00:53:51,780
>> WONDERFUL.  SO THE NEXT

1460
00:53:51,780 --> 00:53:58,787
QUESTION IS, WILL NIAID 

1461
00:53:58,787 --> 00:53:59,388
ESTABLISH AN INTRAMURAL GROUP 

1462
00:53:59,388 --> 00:54:00,022
TO COORDINATE THESE TRIALS? AND 

1463
00:54:00,022 --> 00:54:02,424
WILL THESE CLINICAL TRIALS GO 

1464
00:54:02,424 --> 00:54:03,092
THROUGH A REVIEW PROCESS?

1465
00:54:03,092 --> 00:54:06,462
>> DR. MARRAZZO: THAT THE 

1466
00:54:06,462 --> 00:54:07,062
QUESTION WE WILL ESTABLISH A 

1467
00:54:07,062 --> 00:54:09,798
GROUP SO THE MODEL WE ARE GOING 

1468
00:54:09,798 --> 00:54:10,399
TO USE IS REALLY WHAT WE HAVE 

1469
00:54:10,399 --> 00:54:11,033
DONE FOR MANY OF HER CLINICAL 

1470
00:54:11,033 --> 00:54:14,903
TRIALS, WHICH HAVE TAKEN PLACE 

1471
00:54:14,903 --> 00:54:17,606
IN THREE BIG DIVISIONS: THE 

1472
00:54:17,606 --> 00:54:18,207
DIVISION OF MICROBIOLOGY AND 

1473
00:54:18,207 --> 00:54:19,575
INFECTIOUS DISEASES, ALL OF THE 

1474
00:54:19,575 --> 00:54:22,678
FLU STUDIES, ALL OF THE STI 

1475
00:54:22,678 --> 00:54:24,380
STUDIES AND THE MALARIA 

1476
00:54:24,380 --> 00:54:25,948
STUDIES. MANY OF THOSE HAVE 

1477
00:54:25,948 --> 00:54:28,217
BEEN DONE THERE. TB. IN THE 

1478
00:54:28,217 --> 00:54:29,018
OTHER BIG GROUP IS THE DIVISION 

1479
00:54:29,018 --> 00:54:39,528
OF AIDS. AND THE DIVISION OF 

1480
00:54:45,167 --> 00:54:45,601
ALLERGY, IMMUNOLOGY AND 

1481
00:54:45,601 --> 00:54:46,168
TRANSPLANTATION IN THE FOOD 

1482
00:54:46,168 --> 00:54:51,974
ALLERGY STUDIES.

1483
00:54:51,974 --> 00:54:52,474
ALL OF THOSE GROUPS HAVE 

1484
00:54:52,474 --> 00:54:53,075
RIGOROUS REVIEWS AND WE ALSO 

1485
00:54:53,075 --> 00:54:54,109
HAVE AN INTERNAL DISCUSSION AS 

1486
00:54:54,109 --> 00:54:56,779
PART OF THE NETWORK THAT WILL 

1487
00:54:56,779 --> 00:54:58,981
HAVE THE OVERSIGHT OF THE 

1488
00:54:58,981 --> 00:55:01,083
CLINICAL TRIALS. SO I THINK WE 

1489
00:55:01,083 --> 00:55:01,617
WILL BUILD HEAVILY ON THE 

1490
00:55:01,617 --> 00:55:02,184
MODELS WE USED FOR PREVIOUS 

1491
00:55:02,184 --> 00:55:04,653
CLINICAL TRIALS. 

1492
00:55:04,653 --> 00:55:05,220
>> THERE IS A QUESTION
ABOUT 

1493
00:55:05,220 --> 00:55:11,560
THE TIMELINE FOR RECOVER TLC. 

1494
00:55:11,560 --> 00:55:13,262
WHEN WILL THE TRIALS BEGIN? 

1495
00:55:13,262 --> 00:55:13,862
WHEN WILL DATA BE AVAILABLE? 

1496
00:55:13,862 --> 00:55:16,265
AND WILL THE NIH CLINICAL 

1497
00:55:16,265 --> 00:55:17,700
CENTER BE A TRIAL SITE? 

1498
00:55:17,700 --> 00:55:19,168
>> DR. MARRAZZO: GOOD
QUESTION 

1499
00:55:19,168 --> 00:55:22,004
AND THINK THERE IS A REASON FOR 

1500
00:55:22,004 --> 00:55:24,039
THE NIH NOT TO BE A TRIAL SITE. 

1501
00:55:24,039 --> 00:55:24,640
WE HAVE MANY PARTICIPANTS IN 

1502
00:55:24,640 --> 00:55:28,143
THE PROGRAM-- GAVE A GREAT 

1503
00:55:28,143 --> 00:55:28,744
PRESENTATION ABOUT THE STUDY 

1504
00:55:28,744 --> 00:55:30,713
THAT IS BEING DONE THERE. 

1505
00:55:30,713 --> 00:55:33,816
ROBERTA DIBIASE (PHONETIC) WAS 

1506
00:55:33,816 --> 00:55:36,685
THERE TALKING ABOUT GINA 

1507
00:55:36,685 --> 00:55:40,055
MONTENEGRO'S STUDY WITH KIDS, 

1508
00:55:40,055 --> 00:55:40,956
AN INCREDIBLE WEALTH OF DATA I 

1509
00:55:40,956 --> 00:55:44,927
WOULD SAY, ABSOLUTELY 

1510
00:55:44,927 --> 00:55:45,527
INCLUSIVE, WOULD BE DELIGHTED 

1511
00:55:45,527 --> 00:55:48,731
TO CONSIDER THAT AGAIN. WE WANT 

1512
00:55:48,731 --> 00:55:49,364
SITES THAT CAN ENROLL THE MOST 

1513
00:55:49,364 --> 00:55:51,633
APPROPRIATE PARTICIPANTS AND DO 

1514
00:55:51,633 --> 00:55:52,301
A GOOD JOB. THAT IS REALLY WHAT 

1515
00:55:52,301 --> 00:55:54,903
I CARE ABOUT. 

1516
00:55:54,903 --> 00:55:55,471
THE TIME I IS A LITTLE TRICKY 

1517
00:55:55,471 --> 00:55:58,674
BECAUSE FIRST OF ALL, IF YOU GO 

1518
00:55:58,674 --> 00:56:01,009
ONLINE AND LOOK FOR POTENTIAL 

1519
00:56:01,009 --> 00:56:06,548
INTERVENTION AGENTS ON LONG 

1520
00:56:06,548 --> 00:56:07,149
COVID, YOU WILL COME UP WITH 

1521
00:56:07,149 --> 00:56:07,916
ONE OF THE SLIDES THAT ONE OF 

1522
00:56:07,916 --> 00:56:09,885
THE PRESENTERS SHOWED. WHICH IS 

1523
00:56:09,885 --> 00:56:10,519
A GIGANTIC LIST OF THINGS THAT 

1524
00:56:10,519 --> 00:56:12,121
PEOPLE HAVE TRIED. SOMETIMES IN 

1525
00:56:12,121 --> 00:56:16,492
DESPERATION. SOMETIMES WITH THE 

1526
00:56:16,492 --> 00:56:17,693
SUPPORT AND INPUT OF THE 

1527
00:56:17,693 --> 00:56:18,293
COMMUNITY OF PEOPLE WHO HAVE 

1528
00:56:18,293 --> 00:56:20,062
BEEN USING THESE THINGS. 

1529
00:56:20,062 --> 00:56:23,499
SO I THINK THE QUESTION IS 

1530
00:56:23,499 --> 00:56:25,300
GOING TO BE, WE HAVE TO DO IN 

1531
00:56:25,300 --> 00:56:25,901
THE NEXT COUPLE MONTHS, VERY 

1532
00:56:25,901 --> 00:56:27,903
DEEP DIVE ON THE LIGHT ESCAPE 

1533
00:56:27,903 --> 00:56:28,537
OF WHAT PEOPLE ARE DOING, WHAT 

1534
00:56:28,537 --> 00:56:29,738
THEY ARE FINDING USEFUL, WHAT 

1535
00:56:29,738 --> 00:56:33,308
MIGHT BE AVAILABLE.  IN THE 

1536
00:56:33,308 --> 00:56:33,876
NEXT THING IS HOW WOULD YOU 

1537
00:56:33,876 --> 00:56:36,812
DESIGN A DRUG, OR HOW WOULD YOU 

1538
00:56:36,812 --> 00:56:38,480
LOOK AT AN EXISTING DRUG TO 

1539
00:56:38,480 --> 00:56:39,047
REPURPOSE? THAT IS ANOTHER 

1540
00:56:39,047 --> 00:56:39,648
THING WE CAN TALK ABOUT THAT 

1541
00:56:39,648 --> 00:56:42,851
MIGHT ADDRESS SOME OF HIS 

1542
00:56:42,851 --> 00:56:43,418
PATHOPHYSIOLOGIC MECHANISMS 

1543
00:56:43,418 --> 00:56:47,890
WHERE LEARNING ABOUT. 

1544
00:56:47,890 --> 00:56:48,490
IT IS A LITTLE BIT LIKE YOU ARE 

1545
00:56:48,490 --> 00:56:49,091
ON THE BALL THAT IS ROLLING; 

1546
00:56:49,091 --> 00:56:50,826
THERE IS A LOT OF DATA COMING 

1547
00:56:50,826 --> 00:56:51,426
OUT. THERE IS A WHOLE PANOPLY 

1548
00:56:51,426 --> 00:56:53,796
OF THINGS THAT PEOPLE ARE 

1549
00:56:53,796 --> 00:56:55,964
USING, TO REALLY HAVE TO DO OUR 

1550
00:56:55,964 --> 00:56:58,000
DUE DILIGENCE I THINK AND LOOK 

1551
00:56:58,000 --> 00:56:58,433
AT THE LANDSCAPE OF 

1552
00:56:58,433 --> 00:56:59,034
INTERVENTIONS. AND THEN ALSO 

1553
00:56:59,034 --> 00:57:00,702
THINK PROACTIVELY ABOUT OKAY, 

1554
00:57:00,702 --> 00:57:03,906
WE HAVE ALL OF THESE. ARE THEY 

1555
00:57:03,906 --> 00:57:05,274
WORTH STUDYING REALLY? OR DO WE 

1556
00:57:05,274 --> 00:57:06,975
LOOK AT THESE MECHANISTIC 

1557
00:57:06,975 --> 00:57:10,679
STUDIES, A COUPLE OF SMALL 

1558
00:57:10,679 --> 00:57:11,280
ONES, TO PURSUE WHAT WE THINK 

1559
00:57:11,280 --> 00:57:12,648
MIGHT BE INVALID BIOLOGIC 

1560
00:57:12,648 --> 00:57:14,183
HYPOTHESIS AND BIOLOGIC 

1561
00:57:14,183 --> 00:57:14,817
INTERVENTION? THAT IS NOT GOING 

1562
00:57:14,817 --> 00:57:17,319
TO BE EASY. IT'S GOING TO TAKE 

1563
00:57:17,319 --> 00:57:19,855
A LOT OF THOUGHT AND A LOT OF 

1564
00:57:19,855 --> 00:57:22,758
HOMEWORK. SO I DON'T WANT TO 

1565
00:57:22,758 --> 00:57:23,358
OVERPROMISE. I WOULD LIKE TO 

1566
00:57:23,358 --> 00:57:23,892
THINK AT LEAST ONE OF THE 

1567
00:57:23,892 --> 00:57:24,459
MECHANISTIC STUDIES SET UP 

1568
00:57:24,459 --> 00:57:27,129
EARLY NEXT YEAR. MAYBE FIRST 

1569
00:57:27,129 --> 00:57:28,897
HALF OF NEXT YEAR. THAT WILL BE 

1570
00:57:28,897 --> 00:57:30,265
VERY AMBITIOUS. MAYBE ANOTHER 

1571
00:57:30,265 --> 00:57:35,938
MONTH LATER. AND MAYBE BY 2026 

1572
00:57:35,938 --> 00:57:36,471
WE ARE READY FOR A LARGE 

1573
00:57:36,471 --> 00:57:37,105
EFFICACY TRIAL. AGAIN I CANNOT 

1574
00:57:37,105 --> 00:57:42,311
PROMISE BECAUSE THERE IS SO 

1575
00:57:42,311 --> 00:57:42,911
MUCH RIDING ON WHAT WE LEARN 

1576
00:57:42,911 --> 00:57:43,478
NEXT YEAR AND WHAT WE WILL 

1577
00:57:43,478 --> 00:57:44,513
LEARN WITH THE RECOVER DATA. 

1578
00:57:44,513 --> 00:57:45,681
THAT IS HOW I WOULD SEE IT. 

1579
00:57:45,681 --> 00:57:49,151
>> DR. MARRAZZO YOU JUST 

1580
00:57:49,151 --> 00:57:51,987
MENTIONED PEDIATRIC PATIENTS.  

1581
00:57:51,987 --> 00:57:52,554
THERE ARE SEVERAL PICTURES 

1582
00:57:52,554 --> 00:57:55,090
COMING IN FROM THE AUDIENCE 

1583
00:57:55,090 --> 00:57:55,724
ABOUT WHETHER OR NOT THERE WILL 

1584
00:57:55,724 --> 00:57:57,492
BE PARALLEL ADULT AND PEDIATRIC 

1585
00:57:57,492 --> 00:58:01,163
PROTOCOLS OR IF PEDIATRIC 

1586
00:58:01,163 --> 00:58:01,797
PATIENTS HAVE TO WAIT FOR DATA 

1587
00:58:01,797 --> 00:58:02,364
TO BE VALIDATED IN ADULTS. 

1588
00:58:02,364 --> 00:58:02,931
MAYBE YOU COULD COMMENT ON 

1589
00:58:02,931 --> 00:58:03,332
THAT. 

1590
00:58:03,332 --> 00:58:05,934
>> DR. MARRAZZO: AGAIN I
THINK 

1591
00:58:05,934 --> 00:58:06,535
I POINTED THAT OUT AS ONE OF 

1592
00:58:06,535 --> 00:58:14,676
THE THINGS-- THE IN SERIES, 

1593
00:58:14,676 --> 00:58:15,277
YOUR STUDIES AND YOU GO ALONG 

1594
00:58:15,277 --> 00:58:15,978
TO GET YOUR DATA, AND NOW WE 

1595
00:58:15,978 --> 00:58:16,578
ARE GOING TO DO A STUDY... WE 

1596
00:58:16,578 --> 00:58:27,122
ARE DOING AN AGE DE-ESCALATION 

1597
00:58:28,223 --> 00:58:28,790
STUDY, STARTING IN OLDER WHERE 

1598
00:58:28,790 --> 00:58:29,291
WE PROBABLY NEED TO THE 

1599
00:58:29,291 --> 00:58:29,925
TEENAGERS AND THEN YOU GO DOWN, 

1600
00:58:29,925 --> 00:58:31,827
THERE ARE SOME STUDIES WE HAVE 

1601
00:58:31,827 --> 00:58:34,296
TO DO THAT. BUT MY ANSWER IS IT 

1602
00:58:34,296 --> 00:58:37,132
WILL DEPEND ON THE 

1603
00:58:37,132 --> 00:58:37,699
INTERVENTION. WHAT I DO NOT 

1604
00:58:37,699 --> 00:58:38,200
WANT TO SEE IS SETTING 

1605
00:58:38,200 --> 00:58:39,701
ARTIFICIAL BARS HI AND SAYING 

1606
00:58:39,701 --> 00:58:40,335
WE ARE GOING TO EXCLUDE PEOPLE 

1607
00:58:40,335 --> 00:58:48,343
LOW 18, BECAUSE THEY ARE BELOW 

1608
00:58:48,343 --> 00:58:48,877
18. AND WHEN WE SET UP AN 

1609
00:58:48,877 --> 00:58:50,012
INTERVENTION AND MAY BE TOTALLY 

1610
00:58:50,012 --> 00:58:50,612
APPROPRIATE FOR SOMEONE ABOVE 

1611
00:58:50,612 --> 00:58:51,213
OR EVEN 12 AND ABOUT, OR EVEN 

1612
00:58:51,213 --> 00:58:51,847
SIX MONTHS AND ABOUT. I DON'T 

1613
00:58:51,847 --> 00:58:52,481
KNOW SO IT WILL DEPEND ON THE 

1614
00:58:52,481 --> 00:58:55,851
AGENT. 

1615
00:58:55,851 --> 00:58:56,451
BUT I DO WANT TO SIGNAL THAT WE 

1616
00:58:56,451 --> 00:58:57,586
WANT TO BE EXPEDIENT AND SAFE.  

1617
00:58:57,586 --> 00:58:59,955
WE WANT TO BE INCLUSIVE. BUT WE 

1618
00:58:59,955 --> 00:59:02,658
WANT TO BE SENSITIVE TO THE 

1619
00:59:02,658 --> 00:59:03,759
FACT THAT KIDS AREN'T ADULTS. 

1620
00:59:03,759 --> 00:59:10,599
WE KNOW THAT. BUT WE DO NOT BUY 

1621
00:59:10,599 --> 00:59:11,166
INTO THE TRADITIONAL MODEL 

1622
00:59:11,166 --> 00:59:11,800
NECESSARY TAKES A LONG TIME TO 

1623
00:59:11,800 --> 00:59:13,235
GET THINGS DONE. 

1624
00:59:13,235 --> 00:59:17,072
>> THANK YOU.  SO WE HAVE 

1625
00:59:17,072 --> 00:59:18,573
ANOTHER QUESTION HERE ABOUT, 

1626
00:59:18,573 --> 00:59:25,547
ARE THERE ANY LESSONS TO BE 

1627
00:59:25,547 --> 00:59:26,148
LEARNED FROM CHRONIC FATIGUE? 

1628
00:59:26,148 --> 00:59:26,748
OR OTHER POST VIRAL SYMPTOMS 

1629
00:59:26,748 --> 00:59:27,349
THAT COULD BE TAKEN TO STUDY 

1630
00:59:27,349 --> 00:59:27,783
LONG COVID?

1631
00:59:27,783 --> 00:59:31,486
>> DR. MARRAZZO:
ABSOLUTELY I 

1632
00:59:31,486 --> 00:59:32,087
THINK THE BIGGEST LESSONS WE 

1633
00:59:32,087 --> 00:59:38,026
TALKED ABOUT-- THERE ARE 

1634
00:59:38,026 --> 00:59:42,998
PROBABLY PAPA BIOLOGIC 

1635
00:59:42,998 --> 00:59:43,598
MECHANISMS-- UNFORTUNATELY WE 

1636
00:59:43,598 --> 00:59:44,232
DO NOT HAVE TIME TO GO IN HERE, 

1637
00:59:44,232 --> 00:59:45,400
PROBABLY BETTER TO GET SOMEBODY 

1638
00:59:45,400 --> 00:59:45,934
WHO HAS BEEN IN THE FIELD 

1639
00:59:45,934 --> 00:59:47,836
LONGER THAN I HAVE, AND CAN 

1640
00:59:47,836 --> 00:59:48,470
REALLY SPEAK TO THOSE THAT ONE 

1641
00:59:48,470 --> 00:59:54,910
OF THE BIGGEST THINGS WE 

1642
00:59:54,910 --> 00:59:58,080
LEARNED AT THIS MEETING WAS THE 

1643
00:59:58,080 --> 00:59:58,714
BARRIER TO PEOPLE PARTICIPATING 

1644
00:59:58,714 --> 01:00:01,984
IN THE STUDIES-- WE HAVE ONE OF 

1645
01:00:01,984 --> 01:00:07,689
THESE CONDITIONS, INFECTIOUS 

1646
01:00:07,689 --> 01:00:08,323
ASSOCIATED CHRONIC CONDITIONS, 

1647
01:00:08,323 --> 01:00:08,957
LARGELY VERY MUCH CHARACTERIZED 

1648
01:00:08,957 --> 01:00:10,625
BY FATIGUE. AND SOMETIMES 

1649
01:00:10,625 --> 01:00:13,695
REDUCED MOBILITY. IT IS 

1650
01:00:13,695 --> 01:00:14,296
IMPOSSIBLE FOR MANY OF THESE 

1651
01:00:14,296 --> 01:00:16,765
AFFECTED PEOPLE TO GET TO 

1652
01:00:16,765 --> 01:00:22,237
CLINICAL TRIAL SITES. 

1653
01:00:22,237 --> 01:00:22,838
IMPOSSIBLE FOR PEOPLE TO COME 

1654
01:00:22,838 --> 01:00:23,438
TO A SITE THAT MAY BE REALLY 

1655
01:00:23,438 --> 01:00:25,774
FAR AWAY. OR ONLY OPEN BETWEEN 

1656
01:00:25,774 --> 01:00:30,612
9 AND 3 P.M. WE WANT TO GET 

1657
01:00:30,612 --> 01:00:31,313
SAMPLES BY 3 PM SO WE CAN SHIP 

1658
01:00:31,313 --> 01:00:36,351
THEM, BLAH BLAH. 

1659
01:00:36,351 --> 01:00:36,918
AND IMPOSSIBLE FOR PEOPLE WHO 

1660
01:00:36,918 --> 01:00:41,390
CAN'T LEAVE THE HOUSE, WHETHER 

1661
01:00:41,390 --> 01:00:44,059
THEY'RE HOMEBOUND OR BEDBOUND 

1662
01:00:44,059 --> 01:00:45,293
TO PARTICIPATE IN THE STUDY SO 

1663
01:00:45,293 --> 01:00:45,861
SOMETIMES THE STUDIES GET A 

1664
01:00:45,861 --> 01:00:47,029
SKEWED VIEW OF THE 

1665
01:00:47,029 --> 01:00:47,629
FUNCTIONALITY OF PARTICIPANTS 

1666
01:00:47,629 --> 01:00:49,965
WHO GET IN TRIALS. 

1667
01:00:49,965 --> 01:00:51,666
SO THE BIGGEST THING I HEARD AT 

1668
01:00:51,666 --> 01:00:52,234
THE MEETING, WAS TO TRY TO 

1669
01:00:52,234 --> 01:00:53,235
THINK ABOUT WAYS TO REPRESENT 

1670
01:00:53,235 --> 01:00:58,774
THE SPECTRUM OF SYMPTOMATIC 

1671
01:00:58,774 --> 01:01:02,411
SEVERITY IN THESE TRIALS.  SO 

1672
01:01:02,411 --> 01:01:03,045
WE REALLY HAVE TO THINK I THINK 

1673
01:01:03,045 --> 01:01:04,246
INCLUSIVELY.

1674
01:01:04,246 --> 01:01:05,580
WE HAVE BEEN FOCUSED A LITTLE 

1675
01:01:05,580 --> 01:01:07,282
MORE ON TRYING TO INCLUDE 

1676
01:01:07,282 --> 01:01:07,783
PEOPLE WITH SEVERE 

1677
01:01:07,783 --> 01:01:12,020
DISABILITIES.  MOSTLY AROUND 

1678
01:01:12,020 --> 01:01:13,255
MOBILITY. SOMETIMES COGNITIVE 

1679
01:01:13,255 --> 01:01:13,789
DISABILITIES IN CLINICAL 

1680
01:01:13,789 --> 01:01:16,124
TRIALS.  I THINK THIS IS A 

1681
01:01:16,124 --> 01:01:19,261
GREAT KIND OF WEDGE TO SORT OF 

1682
01:01:19,261 --> 01:01:19,895
SAY, THIS IS A PLACE WE REALLY 

1683
01:01:19,895 --> 01:01:21,029
HAVE TO DO WITH IT. 

1684
01:01:21,029 --> 01:01:23,432
>> GREAT. DR. MARRAZZO
THANK 

1685
01:01:23,432 --> 01:01:26,101
YOU SO MUCH.  UNFORTUNATELY WE 

1686
01:01:26,101 --> 01:01:29,671
ARE AT THE TOP OF THE HOUR. AND 

1687
01:01:29,671 --> 01:01:30,238
YOU ARE RIGHT WE COULD KEEP 

1688
01:01:30,238 --> 01:01:30,806
GOING ON AND ON AND TALKING 

1689
01:01:30,806 --> 01:01:31,373
ABOUT THIS FOR A LONG TIME. 

1690
01:01:31,373 --> 01:01:33,542
THANK YOU SO MUCH FOR YOUR 

1691
01:01:33,542 --> 01:01:34,109
TIME, AND FOR SHARING THIS 

1692
01:01:34,109 --> 01:01:38,013
WONDERFUL INITIATIVE WITH US.  

1693
01:01:38,013 --> 01:01:38,547
WE REALLY LOOK FORWARD TO 

1694
01:01:38,547 --> 01:01:40,282
HEARING ABOUT THE WONDERFUL AND 

1695
01:01:40,282 --> 01:01:41,016
IMPORTANT INFORMATION THAT WE 

1696
01:01:41,016 --> 01:01:45,287
LEARNED FROM RECOVER-TLC.

1697
01:01:45,287 --> 01:01:45,854
TO OUR AUDIENCE THANK YOU SO 

1698
01:01:45,854 --> 01:01:49,224
MUCH FOR JOINING US. WILL SEE 

1699
01:01:49,224 --> 01:01:49,858
YOU AT THE NEXT EXERCISE. HAVE 

1700
01:01:49,858 --> 01:01:51,093
A GREAT AFTERNOON. 

1701
01:01:51,093 --> 01:02:01,093
>> BYE-BYE.