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COVID-19CORC LTONCT05394025

COVID-19 Observational Research Collaboratory

An observational study of COVID-19 and SARS-CoV-2 Infection, run by VA Office of Research and Development at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2 Infection
How many people
479 participants
Where
6 sitesUnited States
Study dates
18 May 2022to 1 Jun 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • VA employees

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105-2303

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

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

    Salt Lake City, Utah, 84148-0001

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

    Seattle, Washington, 98108-1532

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

    West Haven, Connecticut, 06516-2770

Other trials in United States

About this study

Official title: COVID-19 Observational Research Collaboratory - Long-Term Outcomes (LTO) Study

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.

Read the 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.

Keywords
COVID-19, SARS-CoV-2 Infection
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05394025
Study groupRoleWhat they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Survey months 18, 24, 30, 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start18 May 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394025
Sponsor's protocol ID
C19 21-279
Acronym
CORC LTO
Status last verified
Jul 2025
First submitted
25 May 2022
Last updated
7 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Beginning six months after the first survey is collected, updated releases of all structured survey items and basic summary scores will be released via VINCI for all VA investigators with appropriate permissions-but specific HIPAA-protected identifiers will not be included. The research information sheet and recruitment letter include the VA's recommended explicit language about this and the option to opt out.

Publications

  • 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.

    PubMed 34673772

  • 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.

    PubMed 36215715

  • 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.

    PubMed 36326761

  • 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.

    PubMed 36367727

  • 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.

    PubMed 36401423

  • 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.

    PubMed 36729454

  • 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.

    PubMed 37220941

  • 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.

    PubMed 37620765

  • 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.

    PubMed 37884839

  • 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.

    PubMed 37903369

  • 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.

    PubMed 38064215

  • 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.

    PubMed 38334995

  • 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.

    PubMed 37603339

  • 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.

    PubMed 38427352

  • 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.

    PubMed 35904783

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and SARS-CoV-2 Infection, run by VA Office of Research and Development at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Instrumental Activities of Daily Living and Activities of Daily Living (I/ADL) Score (time frame: Survey months 18, 24, 30, 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05394025, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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