Rapid implementation of a cohort for the study of post-acute sequelae of SARS-CoV-2 infection/COVID-19

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.

BACKGROUND: As 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). METHODS: From 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. RESULTS: We 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. CONCLUSION: Among 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.