VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Data on SARS-CoV-2 testing, COVID-19 treatment, comorbidities, and other COVID-19-related information are available through the VA COVID-19 Shared Data Resource data domain within the VA Corporate Data Warehouse (CDW).

Phenotype algorithm for identifying VA convalescent plasma recipients in the EHR is under development.

Available Documentation

• Data dictionary describing the data elements used will be made available on the VA Centralized Interactive Phenomics Resource (CIPHER), (link internal to VA). CIPHER is a catalog of EHR-based phenotype algorithms, definitions, and metadata
• Convalescent plasma phenotype will also be available on CIPHER’s VA COVID-19 Shared Data Resource page. (link internal to VA)

Dates Data are Available

• Data currently available in VA EHR
• Metadata estimated to be available in FY2022

Access Criteria

Veterans Health Administration (VHA) researchers can request access to VHA data sources and data access tools for a research protocol approved by a VA Research and Development (R&D) Committee and reviewed by an Institutional Review Board (IRB). Information about requesting access to http://vaww.vhadataportal.med.va.gov/DataAccess/ResearchAccess.aspx (internal to VA)

Study Characteristics

Objectives

Assess whether convalescent plasma therapy is associated with reduced 30-day mortality in a population of Veteran inpatients with non-severe coronavirus disease 2019 (COVID-19)

Era of Service

All

Population

Eligibility criteria include:  

• U.S. Veterans aged 21–80 years
• Hospitalized between 1 May 2020 and 17 November 2020 with a SARS-CoV-2 positive test, at a VA Medical Center where convalescent plasma had been administered to at least 1 patient and remained a current practice at that VA Medical Center
• A SARS-CoV-2 positive test within 7 days before or after hospital admission
• No prior treatment with convalescent plasma
• No long-term care in a domiciliary or nursing home in the past 90 days
• Minimum oxygen saturation (measured within the past day) ≥90%
• No prior intubation, ventilation, high flow oxygen, extracorporeal membrane oxygenation, dialysis, or vasopressors during current hospitalization
• Vitals (pulse, respiration, temperature, systolic blood pressure) and acute labs (hemoglobin, platelet, white blood cells) measured within the past 2 days
• Albumin, alanine aminotransferase, creatinine measured within the past 30 days
• Weight measurement recorded in the past 2 years

Study Design

An EHR-based study emulating a (hypothetical) target trial using observational data from a cohort of Veteran inpatients with non-severe COVID-19. The intervention was convalescent plasma initiated within 2 days of eligibility. Thirty-day mortality was compared using cumulative incidence curves, risk differences, and hazard ratios estimated from pooled logistic models with inverse probability weighting to adjust for confounding.                      

Intervention

COVID-19 convalescent plasma therapy

Time Period

Analyses restricted to patients hospitalized at a VA medical center between May 1 and November 17, 2020

Setting

National

N

4,755 participants, including 402 participants who received convalescent plasma and 4,353 participants who did not

Response Rate

Not applicable for this study design

Recruitment Method

• Convalescent plasma group: identified from lists provided by the VA Pathology and Laboratory Medicine Service and the Mayo Clinic Convalescent Plasma Expanded Access Program
• Non-convalescent plasma group: identified from the VA COVID-19 Shared Data Resource data domain of the VA Corporate Data Warehouse

Compensation

None

Data Collected

• Sociodemographic information
• COVID-19 severity indicators (oxygen saturation levels, treatment with high-flow oxygen, mechanical ventilation, intubation, dialysis, vasoactive or inotropic infusion, or extracorporeal membrane oxygenation)
• Vitals (e.g., pulse, respiration, temperature, systolic blood pressure)
• Labs (e.g., D-dimer, white blood cells, platelet, albumin, creatinine)
• Comorbidities (e.g., chronic obstructive pulmonary disease, diabetes, hypertension)
• Treatments (e.g., remdesivir, glucocorticoids)
• All-cause mortality

Data Collection Methods

Extraction of VA electronic health record data on patients from the VA Corporate Data Warehouse

Funding Source

VA Office of Research and Development (ORD)

Investigators

Study Chair: Nicholas L. Smith, PhD
Study Chair: Michael J. Gaziano, MD, MPH

Contact

SeattleCSPEC@va.gov

Selected Publications

Cho K, Keithly SC, Kurgansky KE, Madenci AL, Gerlovin H, Wellman HM, Doubleday A, Thomas ER, Park Y, Ho YA, Sugimoto JD, Moore KP, Peterson AC, Hoag C, Gupta K, Jeans K, Klote M, Ramoni R, Huang GD, Casas JP, Gagnon DR, Hernán MA, Smith NL, Gaziano JM. Early Convalescent Plasma Therapy and Mortality among US Veterans Hospitalized with Non-Severe COVID-19: An Observational Analysis Emulating a Target Trial. J Infect Dis. 2021 Jun 21:jiab330. PMID: 34153099; PMCID: PMC8411382.

More Information

• Study ClinicalTrials.gov site
• ClinicalTrials.gov Identifier: NCT04545047
• Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)