VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Participant contact information: Names and contact information of participants who agreed to be contacted for further research, with potential for linkage to research data (SAS, Stata, SPSS, Excel, CSV, and text file formats). This information will only be available via the participant registry once the study finishes active data collection.

Research data: Individual participant data collected during the study (SAS, Stata, SPSS, Excel, CSV, and text file formats)

Biospecimens:

• Blood: EDTA (peripheral blood mononucleocytes and plasma), citrated plasma (buffy coat and plasma), serum separator tubes, PAXGene RNA tubes
• Respiratory: nasal/oral/nasopharyngeal/oropharyngeal swabs, saliva, sputum
• Other research: stool
• Clinical residual specimens of different types
  

Samples will be de-identified or coded, as appropriate

Available Documentation

• Data dictionary
• Case report forms
• Other study documentation

Dates Data are Available

Upon completion of study objectives

Access Criteria

Final data sets and biospecimens will be deposited into a VA data repository. These resources will be shared with qualified VA and non-VA investigators working for nonprofit, academic, and research centers under controlled access procedures via the study repository's application process. Requests will be reviewed for scientific and ethical merit. If the request involves human subjects research, access is contingent upon approval by an Institutional Review Board (IRB) and, if VA research, by a VA Research and Development (R&D) Committee. Before resources are transferred, requestors may be required to sign a VA Data Use Agreement and/or Material Transfer Agreement. Requestors must be fully compliant with any applicable VA data security, privacy, confidentiality, and human subjects requirements.

Study Characteristics

Objectives

To answer key research questions about SARS-CoV-2 infection and COVID-19 natural history, clinical outcomes, treatment/preventions, and the development of immunity while also gathering biospecimens for future study as questions emerge about this new pathogen and other health conditions affecting Veterans.

Era of Service

All

Population

• Veterans aged 18 years or older, and who are receiving healthcare at VHA
• Veterans confirmed to be positive or negative by reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 infection and who are receiving inpatient care at VHA facilities or outpatient care at VHA facilities. In addition, Veterans residing in participating VA Medical Center (VAMC)-operated medium and long-term care facilities, such as Community Living Centers (CLCs) are eligible to enroll, regardless of their whether or not they have been tested for SARS-CoV-2 infection by RT-PCR. 
  

Study Design

Longitudinal observational (non-interventional) cohort study of Veterans. There are three sub-cohorts in the study: 1) inpatients, 2) outpatients, and 3) residents at CLCs.

Time Period

July 2020 - at least June 2024

Setting

National

N

Up to 1,696 participants

Response Rate

Information pending completion of data collection phase

Recruitment Method

1. Inpatients and outpatients with a confirmed RT-PCR test result 21 or fewer days prior to admission (inpatients) or visit (outpatients) to a participating VAMC are identified from lab reports via VA Informatics and Computing Infrastructure (VINCI) (Corporate Data Warehouse (CDW), updated nightly).
2. Clinical staff approach inpatients and explain the purpose of the study. If the inpatient expresses interest, research staff will contact the inpatient for recruitment and informed consenting.
   Recruitment flyers are posted in the outpatient settings (primarily SARS-CoV-2 testing sites) at participating VAMCs. Outpatients who express interest at time of follow-up will be consented by phone and will be mailed study materials.
3. CLC residents will all be informed about the study. Clinical staff will approach residents to explain the purpose of the study. If the resident expresses interest, research staff will contact the patient for recruitment and informed consenting. 

Compensation

Inpatient: Those agreeing to participate will be compensated $150 at the completion of the first part of the study, which covers the time in hospital. If the inpatient SARS-CoV-2 tests negative, the inpatient will still be compensated the $150. Participants who complete each follow-up visit on days 3, 7, 14, 21 and 28, and at months 3, 6, 12, 18, and 24 post-discharge will be paid $50 per visit. The greatest amount a participant could be compensated for contiguous participation in the inpatient cohort is $650.

Outpatient: Those accepting to participate and providing consent will be offered $100 at the completion of the first part of the study, which covers daily data collection for the period of their quarantine or isolation period (approximately 14 days, or until 7 days after the last COVID-19 associated symptom, whichever is longer). For completion of each follow-up visit on days 3, 7, 14, 21, and 28, and at months 3, 6, 12, 18, and 24 after enrollment, participants will be paid $50. The greatest amount a participant could be compensated for contiguous participation in the outpatient cohort is $600.

CLC: Those accepting to participate and signing the consent form, will be offered $100 at the completion of the baseline study visit. At 3, 6, 9, 12, 15, 18, 21 and 24 months, additional blood draws will be performed, and participants will be paid $50 for each draw. The total amount a participant could be compensated is $500.  If a member of the CLC cohort is discharged from their CLC facility into an inpatient or outpatient schedule, the study protocol allows for this individual to switch to the Inpatient/Outpatient data/specimen collection schedule, which would lead to their total possible amount of compensation being $600 ($100 for baseline CLC cohort study visit + $50 times 10 possible follow up visits under the Inpatient/Outpatient data/specimen collection schedule).

Data Collected

• Socio-demographics, personal and family medical history, lifestyle factors, and COVID-19 related factors
• Infection symptoms that participants might be experiencing
• Receipt of SARS-CoV-2 vaccine doses
• Function status and longer-term symptoms of COVID-19
• Blood and respiratory samples throughout participation in the study
• Other biospecimens (saliva, nasal/oral/rectal swabs, stool, urine, or other samples)

Data Collection Methods 

• Questionnaires (interview)
• Clinical assessment data pulled from the VHA Electronic Health Record (EHR)
• Biospecimens collected either from existing residual clinical samples or newly-collected research samples

Funding Source

VA Cooperative Studies Program (CSP)

Investigators

Principal Investigator/Study Chair: Jennifer S. Lee, MD, PhD
Co-Principal Investigator/Study Chair: Jennifer M. Ross, MD, MPH

Contact

CSP2028CC@va.gov

Selected Publication

None at this time

More Information

• Study ClinicalTrials.gov site
• ClinicalTrials.gov Identifier: NCT05764083
• Study website