Clinical trial NCT05394025: COVID-19 Observational Research Collaboratory
Official title: COVID-19 Observational Research Collaboratory - Long-Term Outcomes (LTO) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: COVID-19
SARS-CoV-2 Infection
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Johns Hopkins University
First posted: 2022-05-27
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

Brief summary: This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2 using electronic health record information and structured surveys.

Detailed description: Background: Early evidence suggests that the frequency and type of long term complications stemming from SARS-CoV-2 infection may depend on the severity of initial presentation. However, additional unidentified factors may also play a role including those related to the individual, the environment and/or the specific strain of the virus. The long-term health impacts of SARS-CoV-2 will have major implications for health care utilization, care processes and quality and costs of care for Veterans, both within the VA and in the community. Over 200,000 Veterans have had COVID-19. Although the long term consequences of this novel illness are unknown, it is clear they will often be significant. The overarching goal in the Long-Term Outcome Study (LTO) is to advance VA HSR\&D research into the consequences and care of COVID-19 infection by developing and releasing integrated multi-modal data and results on long-term outcomes of COVID for use by VA clinical, research and operations communities. The investigators will do so via a coordinated program of data production and analysis using the VA electronic health record (EHR) and other administrative sources (e.g., Medicare), de novo longitudinal survey, and qualitative inquiry. This work will be closely coordinated with the COVID-19 Observational Research Collaboratory (CORC) Coordinating Center (CCC) and the burgeoning community of HSR\&D-funded COVID researchers.

This study aims to examine the long-term outcomes in Veterans infected and uninfected with SARS-CoV-2.

Aim 1: Using VINCI-CDW data, patients will be identified who had a SARS-CoV-2 test since February 2020. The investigators will use a combination of traditional epidemiologic studies, and machine learning algorithms to determine the long term, multi-systemic and functional adverse outcomes and/or syndromes related to SARS-CoV-2. Members of the research team are currently developing methods to identify new onset and exacerbations in comorbidities following SARS-CoV-2 illness in Veterans.

Aim 2: Determine Veteran-Reported Outcome Effects Using Structured Survey on domains such as self- reported symptoms, disability, and financial impacts, measured repeatedly over 36 months.

Eligibility criteria: Inclusion Criteria:

All VA enrollees since February 2020, which includes all patients who were tested for SARS-CoV-2 and are included in the VA COVID-19 Shared Data Resource in CDW.

Exclusion Criteria:

VA employees

Primary outcomes:
measure: Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score Change
timeFrame: Survey months 18, 24, 30, 36
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System, Salt Lake City, UT
state: Utah
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Denise M. Hynes, PhD MPH RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center, Durham, NC
name: Matthew L Maciejewski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Amy S Bohnert, PhD MHS BA
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Elizabeth M Viglianti, MD MPH MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Ann M. O'Hare, MD MA
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: George N. Ioannou, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ioannou GN, Ferguson JM, O'Hare AM, Bohnert ASB, Backus LI, Boyko EJ, Osborne TF, Maciejewski ML, Bowling CB, Hynes DM, Iwashyna TJ, Saysana M, Green P, Berry K. Changes in the associations of race and rurality with SARS-CoV-2 infection, mortality, and case fatality in the United States from February 2020 to March 2021: A population-based cohort study. PLoS Med. 2021 Oct 21;18(10):e1003807. doi: 10.1371/journal.pmed.1003807. eCollection 2021 Oct.
citation: Ioannou GN, Bohnert ASB, O'Hare AM, Boyko EJ, Maciejewski ML, Smith VA, Bowling CB, Viglianti E, Iwashyna TJ, Hynes DM, Berry K; COVID-19 Observational Research Collaboratory (CORC). Effectiveness of mRNA COVID-19 Vaccine Boosters Against Infection, Hospitalization, and Death: A Target Trial Emulation in the Omicron (B.1.1.529) Variant Era. Ann Intern Med. 2022 Dec;175(12):1693-1706. doi: 10.7326/M22-1856. Epub 2022 Oct 11.
citation: O'Hare AM, Vig EK, Iwashyna TJ, Fox A, Taylor JS, Viglianti EM, Butler CR, Vranas KC, Helfand M, Tuepker A, Nugent SM, Winchell KA, Laundry RJ, Bowling CB, Hynes DM, Maciejewski ML, Bohnert ASB, Locke ER, Boyko EJ, Ioannou GN; VA COVID Observational Research Collaboratory (CORC). Complexity and Challenges of the Clinical Diagnosis and Management of Long COVID. JAMA Netw Open. 2022 Nov 1;5(11):e2240332. doi: 10.1001/jamanetworkopen.2022.40332.
citation: Bajema KL, Wang XQ, Hynes DM, Rowneki M, Hickok A, Cunningham F, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Viglianti EM, Streja E, Yan L, Aslan M, Huang GD, Ioannou GN. Early Adoption of Anti-SARS-CoV-2 Pharmacotherapies Among US Veterans With Mild to Moderate COVID-19, January and February 2022. JAMA Netw Open. 2022 Nov 1;5(11):e2241434. doi: 10.1001/jamanetworkopen.2022.41434.
citation: Admon AJ, Wander PL, Iwashyna TJ, Ioannou GN, Boyko EJ, Hynes DM, Bowling CB, Bohnert ASB, O'Hare AM, Smith VA, Pura J, Hebert PL, Wong ES, Niederhausen M, Maciejewski ML. Consensus elements for observational research on COVID-19-related long-term outcomes. Medicine (Baltimore). 2022 Nov 18;101(46):e31248. doi: 10.1097/MD.0000000000031248.
citation: Bajema KL, Rowneki M, Berry K, Bohnert A, Bowling CB, Boyko EJ, Iwashyna TJ, Maciejewski ML, O'Hare AM, Osborne TF, Viglianti EM, Hynes DM, Ioannou GN. Rates of and Factors Associated With Primary and Booster COVID-19 Vaccine Receipt by US Veterans, December 2020 to June 2022. JAMA Netw Open. 2023 Feb 1;6(2):e2254387. doi: 10.1001/jamanetworkopen.2022.54387.
citation: Bohnert AS, Kumbier K, Rowneki M, Gupta A, Bajema K, Hynes DM, Viglianti E, O'Hare AM, Osborne T, Boyko EJ, Young-Xu Y, Iwashyna TJ, Maciejewski M, Schildhouse R, Dimcheff D, Ioannou GN. Adverse outcomes of SARS-CoV-2 infection with delta and omicron variants in vaccinated versus unvaccinated US veterans: retrospective cohort study. BMJ. 2023 May 23;381:e074521. doi: 10.1136/bmj-2022-074521.
citation: Smith VA, Berkowitz TSZ, Hebert P, Wong ES, Niederhausen M, Pura JA, Berry K, Green P, Korpak A, Fox A, Baraff A, Hickok A, Shahoumian TA, Bohnert ASB, Hynes DM, Boyko EJ, Ioannou GN, Iwashyna TJ, Bowling CB, O'Hare AM, Maciejewski ML. Correction: Design and analysis of outcomes following SARS-CoV-2 infection in veterans. BMC Med Res Methodol. 2023 Aug 25;23(1):194. doi: 10.1186/s12874-023-02021-4. No abstract available.
citation: Hynes DM, Niederhausen M, Chen JI, Shahoumian TA, Rowneki M, Hickok A, Shepherd-Banigan M, Hawkins EJ, Naylor J, Teo A, Govier DJ, Berry K, McCready H, Osborne TF, Wong E, Hebert PL, Smith VA, Bowling CB, Boyko EJ, Ioannou GN, Iwashyna TJ, Maciejewski ML, O'Hare AM, Viglianti EM, Bohnert AS. Risk of Suicide-Related Outcomes After SARS-COV-2 Infection: Results from a Nationwide Observational Matched Cohort of US Veterans. J Gen Intern Med. 2024 Mar;39(4):626-635. doi: 10.1007/s11606-023-08440-9. Epub 2023 Oct 26.
citation: Ioannou GN, Berry K, Rajeevan N, Li Y, Mutalik P, Yan L, Bui D, Cunningham F, Hynes DM, Rowneki M, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Osborne TF, Viglianti EM, Aslan M, Huang GD, Bajema KL. Effectiveness of Nirmatrelvir-Ritonavir Against the Development of Post-COVID-19 Conditions Among U.S. Veterans : A Target Trial Emulation. Ann Intern Med. 2023 Nov;176(11):1486-1497. doi: 10.7326/M23-1394. Epub 2023 Oct 31.
citation: Wander PL, Baraff A, Fox A, Cho K, Maripuri M, Honerlaw JP, Ho YL, Dey AT, O'Hare AM, Bohnert ASB, Boyko EJ, Maciejewski ML, Viglianti E, Iwashyna TJ, Hynes DM, Osborne TF, Ioannou GN. Rates of ICD-10 Code U09.9 Documentation and Clinical Characteristics of VA Patients With Post-COVID-19 Condition. JAMA Netw Open. 2023 Dec 1;6(12):e2346783. doi: 10.1001/jamanetworkopen.2023.46783.
citation: Hebert PL, Kumbier KE, Smith VA, Hynes DM, Govier DJ, Wong E, Kaufman BG, Shepherd-Banigan M, Rowneki M, Bohnert ASB, Ioannou GN, Boyko EJ, Iwashyna TJ, O'Hare AM, Bowling CB, Viglianti EM, Maciejewski ML; VA COVID-19 Observational Research Collaboratory (CORC). Changes in Outpatient Health Care Use After COVID-19 Infection Among Veterans. JAMA Netw Open. 2024 Feb 5;7(2):e2355387. doi: 10.1001/jamanetworkopen.2023.55387.
citation: Iwashyna TJ, Seelye S, Berkowitz TS, Pura J, Bohnert ASB, Bowling CB, Boyko EJ, Hynes DM, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Womer J, Prescott HC, Smith VA; VA HSR&D COVID-19 Observational Research Collaboratory. Late Mortality After COVID-19 Infection Among US Veterans vs Risk-Matched Comparators: A 2-Year Cohort Analysis. JAMA Intern Med. 2023 Oct 1;183(10):1111-1119. doi: 10.1001/jamainternmed.2023.3587.
citation: Iwashyna TJ, Smith VA, Seelye S, Bohnert ASB, Boyko EJ, Hynes DM, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Berkowitz TS, Pura J, Womer J, Kamphuis LA, Monahan ML, Bowling CB; VA HSR&D COVID-19 Observational Research Collaboratory (CORC). Self-Reported Everyday Functioning After COVID-19 Infection. JAMA Netw Open. 2024 Mar 4;7(3):e240869. doi: 10.1001/jamanetworkopen.2024.0869.
citation: Ioannou GN, Baraff A, Fox A, Shahoumian T, Hickok A, O'Hare AM, Bohnert ASB, Boyko EJ, Maciejewski ML, Bowling CB, Viglianti E, Iwashyna TJ, Hynes DM. Rates and Factors Associated With Documentation of Diagnostic Codes for Long COVID in the National Veterans Affairs Health Care System. JAMA Netw Open. 2022 Jul 1;5(7):e2224359. doi: 10.1001/jamanetworkopen.2022.24359.
citation: Chen JI, Bui D, Iwashyna TJ, Shahoumian TA, Hickok A, Shepherd-Banigan M, Hawkins EJ, Naylor J, Govier DJ, Osborne TF, Smith VA, Bowling CB, Boyko EJ, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Bohnert AS, Hynes DM; V. A. HSRDSARS-C.O.V.-2 Observational Research Collaboratory (CORC). Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans. J Gen Intern Med. 2024 Jun;39(8):1310-1316. doi: 10.1007/s11606-024-08630-z. Epub 2024 Apr 16.
citation: Chen JI, Bui D, Iwashyna TJ, Shahoumian TA, Hickok A, Shepherd-Banigan M, Hawkins EJ, Naylor J, Govier DJ, Osborne TF, Smith VA, Bowling CB, Boyko EJ, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Bohnert AS, Hynes DM; V. A. HSRDSARS-C.O.V.-2 Observational Research Collaboratory (CORC). Correction to: Impact of SARS-CoV-2 Infection on Long-Term Depression Symptoms among Veterans. J Gen Intern Med. 2024 May 14. doi: 10.1007/s11606-024-08800-z. Online ahead of print. No abstract available.
citation: Hauschildt KE, Bui DP, Govier DJ, Eaton TL, Viglianti EM, Ettman CK, McCready H, Smith VA, O'Hare AM, Osborne TF, Boyko EJ, Ioannou GN, Maciejewski ML, Bohnert ASB, Hynes DM, Iwashyna TJ; VA COVID-19 Observational Research Collaboratory (CORC). Regional variation in financial hardship among US veterans during the COVID-19 pandemic. Health Aff Sch. 2024 Jun 5;2(6):qxae075. doi: 10.1093/haschl/qxae075. eCollection 2024 Jun.
citation: Govier DJ, Bui DP, Hauschildt KE, Eaton TL, McCready H, Smith VA, Osborne TF, Bowling CB, Boyko EJ, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Bohnert ASB, Hynes DM, Iwashyna TJ. Financial hardship after COVID-19 infection among US Veterans: a national prospective cohort study. BMC Health Serv Res. 2024 Aug 19;24(1):943. doi: 10.1186/s12913-024-11421-1.
citation: Ioannou GN, Berry K, Rajeevan N, Li Y, Yan L, Huang Y, Lin HM, Bui D, Hynes DM, Rowneki M, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Smith VA, Berkowitz TSZ, O'Hare AM, Viglianti EM, Aslan M, Bajema KL. Effectiveness of the 2023-to-2024 XBB.1.5 COVID-19 Vaccines Over Long-Term Follow-up : A Target Trial Emulation. Ann Intern Med. 2025 Mar;178(3):348-359. doi: 10.7326/ANNALS-24-01015. Epub 2025 Feb 4.