Study Results
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View full resultsBasic Information
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COMPLETED
479 participants
OBSERVATIONAL
2022-05-18
2024-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Veterans who tested positive for COVID-19 (case)
The investigators will organize the sampling of cases (and later of comparators) around the waves of the epidemic, as defined by their nadirs between national death rates-each approximately 3-4 months long. The investigators will initiate surveys of Veterans who have survived their initial SARS-CoV-2 infection. The viral infection "index date" will be defined as date of each patient's first positive test.
No interventions assigned to this group
Veterans who did not test positive for COVID-19 (comparator)
To support causal inference, the investigators will also sample Veterans without COVID who are matched to participants with COVID-19. In general, cases will be compared to comparators matched on risk of developing COVID infection during a given wave.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Denise M. Hynes, PhD MPH RN
Role: PRINCIPAL_INVESTIGATOR
VA Portland Health Care System, Portland, OR
Matthew L Maciejewski, PhD
Role: PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC
Amy S Bohnert, PhD MHS BA
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Elizabeth M Viglianti, MD MPH MSc
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann M. O'Hare, MD MA
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
George N. Ioannou, MD MS
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Locations
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Chen JI, Niederhausen M, Bui DP, Govier DJ, Rowneki M, Hickok A, Shahoumian TA, Shepherd-Banigan M, Korpak A, Hawkins E, Teo AR, Naylor J, Osborne TF, Smith VA, Bowling CB, Boyko EJ, Ioannou GN, Maciejewski ML, O'Hare AM, Viglianti EM, Iwashyna TJ, Bohnert ASB, Hynes DM; VA HSR&D COVID-19 Observational Research Collaboratory (CORC). Veteran Mental Health Emergency Care Utilization Following SARS-CoV-2 Infection. Health Serv Res. 2025 Oct;60(5):e14622. doi: 10.1111/1475-6773.14622. Epub 2025 Jun 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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VA COVID-19 Observational Research Collaboratory Website
Other Identifiers
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C19 21-279
Identifier Type: -
Identifier Source: org_study_id
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