COVID-19 Observational Research Collaboratory

COVID-19 Clinical Trial

— CORC LTO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05394025
• Other study ID #: C19 21-279
• Status: Enrolling by invitation
• Start date: May 18, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3600
• Est. completion date: September 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Locations

Country	Name	City	State
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	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (15)

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 outcome — View 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, Decem — View 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 Mil — View 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 vari — View Citation

Burns KEA, Moss M, Lorens E, Jose EKA, Martin CM, Viglianti EM, Fox-Robichaud A, Mathews KS, Akgun K, Jain S, Gershengorn H, Mehta S, Han JE, Martin GS, Liebler JM, Stapleton RD, Trachuk P, Vranas KC, Chua A, Herridge MS, Tsang JLY, Biehl M, Burnham EL, C — View 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 — View 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, — View 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 th — View 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, Hospi — View 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. — View 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 COV — View 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 Resea — View Citation

Robinson-Lane SG, Leggett AN, Johnson FU, Leonard N, Carmichael AG, Oxford G, Miah T, Wright JJ, Blok AC, Iwashyna TJ, Gonzalez R. Caregiving in the COVID-19 pandemic: Family adaptations following an intensive care unit hospitalisation. J Clin Nurs. 2024 — View 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 — View 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 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activities of Daily Living Scale (ADL) Change	Measures level of disability on a scale from 0 - 6, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time.	Survey months 12, 18, 24, 30, 36
Primary	Instrumental Activities of Daily Living (IADL) Change	Measures level of disability on a scale from 0 - 8, where higher values are considered a worse outcome. Multiple survey timepoints will allow us to assess change in disability over time.	Survey months 12, 18, 24, 30, 36

External Links

•   VA COVID-19 Observational Research Collaboratory Website