Stephanie M LaVergne1, Sophia Stromberg2, Bridget A Baxter1, Tracy L Webb3, Taru S Dutt4, Kailey Berry5, Madison Tipton5, Jared Haberman5, Benjamin R Massey6, Kim McFann7, Omar Alnachoukati7, Linda Zier7, Thomas Heacock7, Gregory D Ebel4, Marcela Henao-Tamayo4, Julie Dunn7, Elizabeth P Ryan8. 1. Department of Environmental and Radiological Health Sciences, Colorado State University, 1601 Campus Delivery, Fort Collins, CO, 80523, USA. 2. Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO, USA. 3. Department of Clinical Sciences, Colorado State University, Fort Collins, CO, USA. 4. Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, USA. 5. Department of Biomedical Sciences, Colorado State University, Fort Collins, CO, USA. 6. University of Colorado Anschutz School of Medicine, Aurora, CO, USA. 7. University of Colorado Health, Medical Center of the Rockies, Loveland, CO, USA. 8. Department of Environmental and Radiological Health Sciences, Colorado State University, 1601 Campus Delivery, Fort Collins, CO, 80523, USA. E.P.Ryan@colostate.edu.
Abstract
BACKGROUND: SARS-CoV-2 has swept across the globe, causing millions of deaths worldwide. Though most survive, many experience symptoms of COVID-19 for months after acute infection. Successful prevention and treatment of acute COVID-19 infection and its associated sequelae is dependent on in-depth knowledge of viral pathology across the spectrum of patient phenotypes and physiologic responses. Longitudinal biobanking provides a valuable resource of clinically integrated, easily accessed, and quality-controlled samples for researchers to study differential multi-organ system responses to SARS-CoV-2 infection, post-acute sequelae of COVID-19 (PASC), and vaccination. METHODS: Adults with a history of a positive SARS-CoV-2 nasopharyngeal PCR are actively recruited from the community or hospital settings to enroll in the Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO). Blood, saliva, stool, nasopharyngeal specimens, and extensive clinical and demographic data are collected at 4 time points over 6 months. Patients are assessed for PASC during longitudinal follow-up by physician led symptom questionnaires and physical exams. This clinical trial registration is NCT04603677 . RESULTS: We have enrolled and collected samples from 119 adults since July 2020, with 66% follow-up rate. Forty-nine percent of participants assessed with a symptom surveillance questionnaire (N = 37 of 75) had PASC at any time during follow-up (up to 8 months post infection). Ninety-three percent of hospitalized participants developed PASC, while 23% of those not requiring hospitalization developed PASC. At 90-174 days post SARS-CoV-2 diagnosis, 67% of all participants had persistent symptoms (N = 37 of 55), and 85% percent of participants who required hospitalization during initial infection (N = 20) still had symptoms. The most common symptoms reported after 15 days of infection were fatigue, loss of smell, loss of taste, exercise intolerance, and cognitive dysfunction. CONCLUSIONS: Patients who were hospitalized for COVID-19 were significantly more likely to have PASC than those not requiring hospitalization, however 23% of patients who were not hospitalized also developed PASC. This patient-matched, multi-matrix, longitudinal biorepository from COVID-19 survivors with and without PASC will allow for current and future research to better understand the pathophysiology of disease and to identify targeted interventions to reduce risk for PASC. Registered 27 October 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04603677 .
BACKGROUND:SARS-CoV-2 has swept across the globe, causing millions of deaths worldwide. Though most survive, many experience symptoms of COVID-19 for months after acute infection. Successful prevention and treatment of acute COVID-19infection and its associated sequelae is dependent on in-depth knowledge of viral pathology across the spectrum of patient phenotypes and physiologic responses. Longitudinal biobanking provides a valuable resource of clinically integrated, easily accessed, and quality-controlled samples for researchers to study differential multi-organ system responses to SARS-CoV-2 infection, post-acute sequelae of COVID-19 (PASC), and vaccination. METHODS: Adults with a history of a positive SARS-CoV-2 nasopharyngeal PCR are actively recruited from the community or hospital settings to enroll in the Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO). Blood, saliva, stool, nasopharyngeal specimens, and extensive clinical and demographic data are collected at 4 time points over 6 months. Patients are assessed for PASC during longitudinal follow-up by physician led symptom questionnaires and physical exams. This clinical trial registration is NCT04603677 . RESULTS: We have enrolled and collected samples from 119 adults since July 2020, with 66% follow-up rate. Forty-nine percent of participants assessed with a symptom surveillance questionnaire (N = 37 of 75) had PASC at any time during follow-up (up to 8 months post infection). Ninety-three percent of hospitalized participants developed PASC, while 23% of those not requiring hospitalization developed PASC. At 90-174 days post SARS-CoV-2 diagnosis, 67% of all participants had persistent symptoms (N = 37 of 55), and 85% percent of participants who required hospitalization during initial infection (N = 20) still had symptoms. The most common symptoms reported after 15 days of infection were fatigue, loss of smell, loss of taste, exercise intolerance, and cognitive dysfunction. CONCLUSIONS:Patients who were hospitalized for COVID-19 were significantly more likely to have PASC than those not requiring hospitalization, however 23% of patients who were not hospitalized also developed PASC. This patient-matched, multi-matrix, longitudinal biorepository from COVID-19 survivors with and without PASC will allow for current and future research to better understand the pathophysiology of disease and to identify targeted interventions to reduce risk for PASC. Registered 27 October 2020 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04603677 .
Authors: Aditi Ramakrishnan; Jennifer Zreloff; Miranda A Moore; Sharon H Bergquist; Michele Cellai; Jason Higdon; James B O'Keefe; David Roberts; Henry M Wu Journal: Open Forum Infect Dis Date: 2021-02-02 Impact factor: 3.835
Authors: Elizabeth J Williamson; Alex J Walker; Krishnan Bhaskaran; Seb Bacon; Chris Bates; Caroline E Morton; Helen J Curtis; Amir Mehrkar; David Evans; Peter Inglesby; Jonathan Cockburn; Helen I McDonald; Brian MacKenna; Laurie Tomlinson; Ian J Douglas; Christopher T Rentsch; Rohini Mathur; Angel Y S Wong; Richard Grieve; David Harrison; Harriet Forbes; Anna Schultze; Richard Croker; John Parry; Frank Hester; Sam Harper; Rafael Perera; Stephen J W Evans; Liam Smeeth; Ben Goldacre Journal: Nature Date: 2020-07-08 Impact factor: 49.962
Authors: Lydia L Shook; Jessica E Shui; Adeline A Boatin; Samantha Devane; Natalie Croul; Lael M Yonker; Juan D Matute; Rosiane S Lima; Muriel Schwinn; Dana Cvrk; Laurel Gardner; Robin Azevedo; Suzanne Stanton; Evan A Bordt; Laura J Yockey; Alessio Fasano; Jonathan Z Li; Xu G Yu; Anjali J Kaimal; Paul H Lerou; Andrea G Edlow Journal: BMC Med Res Methodol Date: 2020-08-26 Impact factor: 4.615
Authors: Francisco Carmona-Torre; Ane Mínguez-Olaondo; Alba López-Bravo; Beatriz Tijero; Vesselina Grozeva; Michaela Walcker; Harkaitz Azkune-Galparsoro; Adolfo López de Munain; Ana Belen Alcaide; Jorge Quiroga; Jose Luis Del Pozo; Juan Carlos Gómez-Esteban Journal: Front Neurol Date: 2022-05-27 Impact factor: 4.086
Authors: Jacqueline E Shanley; Andrew F Valenciano; Garrett Timmons; Annalise E Miner; Visesha Kakarla; Torge Rempe; Jennifer H Yang; Amanda Gooding; Marc A Norman; Sarah J Banks; Michelle L Ritter; Ronald J Ellis; Lucy Horton; Jennifer S Graves Journal: Ann Clin Transl Neurol Date: 2022-06-15 Impact factor: 5.430
Authors: Kendra M Quicke; Bridget A Baxter; Sophia Stromberg; Emily N Gallichotte; Emily Fitzmeyer; Michael C Young; Kristy L Pabilonia; Nicole Ehrhart; Julie Dunn; Gregory D Ebel; Elizabeth P Ryan Journal: Adv Virol Date: 2022-08-08
Authors: Sophia Stromberg; Bridget A Baxter; Gregory Dooley; Stephanie M LaVergne; Emily Gallichotte; Taru Dutt; Madison Tipton; Kailey Berry; Jared Haberman; Nicole Natter; Tracy L Webb; Kim McFann; Marcela Henao-Tamayo; Greg Ebel; Sangeeta Rao; Julie Dunn; Elizabeth P Ryan Journal: Front Nutr Date: 2022-09-14
Authors: Anne M Neilan; Anisha Tyagi; Yao Tong; Eva J Farkas; Madeleine D Burns; Allison Fialkowski; Grace Park; Margot Hardcastle; Elizabeth Gootkind; Ingrid V Bassett; Fatma M Shebl; Lael M Yonker Journal: BMC Pediatr Date: 2022-03-12 Impact factor: 2.125