Rapid implementation of a cohort for the study of post-acute sequelae of SARS-CoV-2 infection/COVID-19
Authors: Peluso Michael J. , Kelly J. Daniel , Lu Scott , Goldberg Sarah A. , Davidson Michelle C. , Mathur Sujata , Durstenfeld Matthew S. , Spinelli Matthew A. , Hoh Rebecca , Tai Viva , Fehrman Emily A. , Torres Leonel , Hernandez Yanel , Williams Meghann C. , Arreguin Mireya I. , Bautista Jennifer A. , Ngo Lynn H. , Deswal Monika , Munter Sadie E. , Martinez Enrique O. , Anglin Khamal A. , Romero Mariela D. , Tavs Jacqueline , Rugart Paulina R. , Chen Jessica Y. , Sans Hannah M. , Murray Victoria W. , Ellis Payton K. , Donohue Kevin C. , Massachi Jonathan A. , Weiss Jacob O. , Mehdi Irum , Pineda-Ramirez Jesus , Tang Alex F. , Wenger Megan , Assenzio Melissa , Yuan Yan , Krone Melissa , Rutishauser Rachel L. , Rodriguez-Barraquer Isabel , Greenhouse Bryan , Sauceda John A. , Gandhi Monica , Hsue Priscilla Y. , Henrich Timothy J. , Deeks Steven G. , Martin Jeffrey N. 
Published: March 2021

ABSTRACTBACKGROUNDAs the coronavirus disease 2019 (COVID-19) pandemic continues and millions remain vulnerable to infection with severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), attention has turned to characterizing post-acute sequelae of SARS-CoV-2 infection (PASC).METHODSFrom April 21 to December 31, 2020, we assembled a cohort of consecutive volunteers who a) had documented history of SARS-CoV-2 RNA-positivity; b) were ≥ 2 weeks past onset of COVID-19 symptoms or, if asymptomatic, first test for SARS-CoV-2; and c) were able to travel to our site in San Francisco. Participants learned about the study by being identified on medical center-based registries and being notified or by responding to advertisements. At 4-month intervals, we asked participants about physical symptoms that were new or worse compared to the period prior to COVID-19, mental health symptoms and quality of life. We described 4 time periods: 1) acute illness (0-3 weeks), 2) early recovery (3-10 weeks), 3) late recovery 1 (12-20 weeks), and 4) late recovery 2 (28-36 weeks). Blood and oral specimens were collected at each visit.RESULTSWe have, to date, enrolled 179 adults. During acute SARS-CoV-2 infection, 10 had been asymptomatic, 125 symptomatic but not hospitalized, and 44 symptomatic and hospitalized. In the acute phase, the most common symptoms were fatigue, fever, myalgia, cough and anosmia/dysgeusia. During the post-acute phase, fatigue, shortness of breath, concentration problems, headaches, trouble sleeping and anosmia/dysgeusia were the most commonly reported symptoms, but a variety of others were endorsed by at least some participants. Some experienced symptoms of depression, anxiety, and post-traumatic stress, as well as difficulties with ambulation and performance of usual activities. The median visual analogue scale value rating of general health was lower at 4 and 8 months (80, interquartile range [IQR]: 70-90; and 80, IQR 75-90) compared to prior to COVID-19 (85; IQR 75-90). Biospecimens were collected at nearly 600 participant-visits.CONCLUSIONAmong a cohort of participants enrolled in the post-acute phase of SARS-CoV-2 infection, we found many with persistent physical symptoms through 8 months following onset of COVID-19 with an impact on self-rated overall health. The presence of participants with and without symptoms and ample biological specimens will facilitate study of PASC pathogenesis. Similar evaluations in a population-representative sample will be needed to estimate the population-level prevalence of PASC.