COVID-19 Observational Research Collaboratory

NCT05394025 | Completed Results

• 1 other identifier: C19 21-279
• Study Type: observational
• Target: 479
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score

  Measures level of disability on a scale from 0 - 14, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time. The score consists of 14 questions about activities of daily living. The I/ADL score is a sum total of reported limitations ranging from 0 (no limitations reported) to 14 (limitations in all activities asked reported).

  Survey months 18, 24, 30, 36

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• VA employees

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Johns Hopkins University: collaborator

Study Sites (6)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (21)

• 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.

  PMID: 34673772 BACKGROUND

• 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.

  PMID: 36215715 RESULT

• 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.

  PMID: 36326761 RESULT

• 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.

  PMID: 36367727 RESULT

• 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.

  PMID: 36401423 RESULT

• 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.

  PMID: 36729454 RESULT

• 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.

  PMID: 37220941 RESULT

• 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.

  PMID: 37620765 RESULT

• 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.

  PMID: 37884839 RESULT

• 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.

  PMID: 37903369 RESULT

• 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.

  PMID: 38064215 RESULT

• 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.

  PMID: 38334995 RESULT

• 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.

  PMID: 37603339 RESULT

• 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.

  PMID: 38427352 RESULT

• 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.

  PMID: 35904783 RESULT

• 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.

  PMID: 38625482 RESULT

• 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.

  PMID: 38743168 RESULT

• 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.

  PMID: 38938272 RESULT

• 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.

  PMID: 39160528 RESULT

• 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.

  PMID: 39903865 RESULT

• 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.

  PMID: 40474431 RESULT

Related Links

• VA COVID-19 Observational Research Collaboratory Website

Biospecimen

Retention: NONE RETAINED

No biospecimens

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

While COVID-19 status was ascertained early in the pandemic through evidence of PCR test, we were unable to ascertain if uninfected comparators became infected over time due to uptake in home testing. This would have resulted in misclassification of the uninfected and biased our results towards the null.

Results Point of Contact

• Title: Project Manager
• Organization: Center to Improve Veteran Involvement in Care (CIVIC), VA Portland Health Care System

Holly.McCready2@va.gov

503-220-8262

Study Officials

• Denise M. Hynes, PhD MPH RN

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

• Matthew L Maciejewski, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Amy S Bohnert, PhD MHS BA

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Elizabeth M Viglianti, MD MPH MSc

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Ann M. O'Hare, MD MA

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

• George N. Ioannou, MD MS

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: May 27, 2022
• Study Start: May 18, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 7, 2025
• Results First Posted: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Releases of survey items and scores will occur every six months and will be available indefinitely
• Access Criteria: Researchers that access this data for future research use may be national or international and affiliated or unaffiliated with the VA, and may only use the data for research purposes. Future studies will have appropriate data use agreements in place as well as receive approval by an IRB and other oversight committees prior to starting any research.

Locations

US (6)