TY - JOUR
T1 - Characterizing Symptoms and Identifying Biomarkers of Long COVID in People With and Without HIV
T2 - Protocol for a Remotely Conducted Prospective Observational Cohort Study
AU - Márquez, Nuria Gallego
AU - Jamal, Armaan
AU - Johnston, Rowena
AU - Richter, E. India
AU - Gorbach, Pamina M.
AU - Vannorsdall, Tracy D.
AU - Rubin, Leah H.
AU - Jennings, Cheryl
AU - Landay, Alan L.
AU - Peluso, Michael J.
AU - Antar, Annukka A.R.
N1 - Publisher Copyright:
© Nuria Gallego Márquez, Armaan Jamal, Rowena Johnston, E India Richter, Pamina M Gorbach, Tracy D Vannorsdall, Leah H Rubin, Cheryl Jennings, Alan L Landay, Michael J Peluso, Annukka A R Antar. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 31.05.2023. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
PY - 2023
Y1 - 2023
N2 - Background: Living with HIV is a risk factor for severe acute COVID-19, but it is unknown whether it is a risk factor for long COVID. Objective: This study aims to characterize symptoms, sequelae, and cognition formally and prospectively 12 months following SARS-CoV-2 infection in people living with HIV compared with people without HIV. People with no history of SARS-CoV-2 infection, both with and without HIV, are enrolled as controls. The study also aims to identify blood-based biomarkers or patterns of immune dysregulation associated with long COVID. Methods: This prospective observational cohort study enrolled participants into 1 of the following 4 study arms: people living with HIV who had SARS-CoV-2 infection for the first time <4 weeks before enrollment (HIV+COVID+ arm), people without HIV who had SARS-CoV-2 infection for the first time within 4 weeks of enrollment (HIV−COVID+ arm), people living with HIV who believed they never had SARS-CoV-2 infection (HIV+COVID− arm), and people without HIV who believed they never had SARS-CoV-2 infection (HIV−COVID− arm). At enrollment, participants in the COVID+ arms recalled their symptoms, mental health status, and quality of life in the month before having SARS-CoV-2 infection via a comprehensive survey administered by telephone or on the web. All participants completed the same comprehensive survey 1, 2, 4, 6, and 12 months after post-acute COVID-19 symptom onset or diagnosis, if asymptomatic, (COVID+ arms) or after enrollment (COVID− arms) on the web or by telephone. In total, 11 cognitive assessments were administered by telephone at 1 and 4 months after symptom onset (COVID+ arms) or after enrollment (COVID− arms). A mobile phlebotomist met the participants at a location of their choice for height and weight measurements, orthostatic vital signs, and a blood draw. Participants in the COVID+ arms donated blood 1 and 4 months after COVID-19, and participants in the COVID− arms donated blood once or none. Blood was then shipped overnight to the receiving study laboratory, processed, and stored. Results: This project was funded in early 2021, and recruitment began in June 2021. Data analyses will be completed by summer 2023. As of February 2023, a total of 387 participants were enrolled in this study, with 345 participants having completed enrollment or baseline surveys together with at least one other completed study event. The 345 participants includes 76 (22%) HIV+COVID+, 121 (35.1%) HIV−COVID+, 78 (22.6%) HIV+COVID−, and 70 (20.3%) HIV−COVID− participants. Conclusions: This study will provide longitudinal data to characterize COVID-19 recovery over 12 months in people living with and without HIV. Additionally, this study will determine whether biomarkers or patterns of immune dsyregulation associate with decreased cognitive function or symptoms of long COVID.
AB - Background: Living with HIV is a risk factor for severe acute COVID-19, but it is unknown whether it is a risk factor for long COVID. Objective: This study aims to characterize symptoms, sequelae, and cognition formally and prospectively 12 months following SARS-CoV-2 infection in people living with HIV compared with people without HIV. People with no history of SARS-CoV-2 infection, both with and without HIV, are enrolled as controls. The study also aims to identify blood-based biomarkers or patterns of immune dysregulation associated with long COVID. Methods: This prospective observational cohort study enrolled participants into 1 of the following 4 study arms: people living with HIV who had SARS-CoV-2 infection for the first time <4 weeks before enrollment (HIV+COVID+ arm), people without HIV who had SARS-CoV-2 infection for the first time within 4 weeks of enrollment (HIV−COVID+ arm), people living with HIV who believed they never had SARS-CoV-2 infection (HIV+COVID− arm), and people without HIV who believed they never had SARS-CoV-2 infection (HIV−COVID− arm). At enrollment, participants in the COVID+ arms recalled their symptoms, mental health status, and quality of life in the month before having SARS-CoV-2 infection via a comprehensive survey administered by telephone or on the web. All participants completed the same comprehensive survey 1, 2, 4, 6, and 12 months after post-acute COVID-19 symptom onset or diagnosis, if asymptomatic, (COVID+ arms) or after enrollment (COVID− arms) on the web or by telephone. In total, 11 cognitive assessments were administered by telephone at 1 and 4 months after symptom onset (COVID+ arms) or after enrollment (COVID− arms). A mobile phlebotomist met the participants at a location of their choice for height and weight measurements, orthostatic vital signs, and a blood draw. Participants in the COVID+ arms donated blood 1 and 4 months after COVID-19, and participants in the COVID− arms donated blood once or none. Blood was then shipped overnight to the receiving study laboratory, processed, and stored. Results: This project was funded in early 2021, and recruitment began in June 2021. Data analyses will be completed by summer 2023. As of February 2023, a total of 387 participants were enrolled in this study, with 345 participants having completed enrollment or baseline surveys together with at least one other completed study event. The 345 participants includes 76 (22%) HIV+COVID+, 121 (35.1%) HIV−COVID+, 78 (22.6%) HIV+COVID−, and 70 (20.3%) HIV−COVID− participants. Conclusions: This study will provide longitudinal data to characterize COVID-19 recovery over 12 months in people living with and without HIV. Additionally, this study will determine whether biomarkers or patterns of immune dsyregulation associate with decreased cognitive function or symptoms of long COVID.
KW - COVID-19
KW - HIV
KW - long COVID
KW - post-acute COVID-19 syndrome
KW - postacute sequelae of SARS-CoV-2 infection
KW - prospective observational cohort study
KW - remote participation
KW - remote study
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85161855104&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85161855104&partnerID=8YFLogxK
U2 - 10.2196/47079
DO - 10.2196/47079
M3 - Article
AN - SCOPUS:85161855104
SN - 1929-0748
VL - 12
JO - JMIR Research Protocols
JF - JMIR Research Protocols
M1 - e47079
ER -