VA CoronavirUs Research and Efficacy Studies-1

As of August 25, 2020, SARS-Coronavirus 2 (SARS-CoV-2; COVID-19) infections are approaching 6
million persons and 180,000 deaths in the US. Of the 20% of patients admitted to hospital, up
to half progress to ICU admission, respiratory failure or death. Prominent among these
progressors are older men, particularly those with underlying comorbidities (e.g.,
hypertension, diabetes, lung, heart, kidney or liver disease, obesity and immunocompromised),
all common among Veterans. There are no drugs or other therapeutics approved by the FDA to
prevent or treat COVID-19 infection.

Convalescent plasma therapy is being used empirically, although only five of six small
uncontrolled case series (total n=56) in SARS-CoV-23-8 and a recent study with non-randomized
controls suggest improved selected clinical, virologic and laboratory outcomes; outcomes in
another small randomized trial were equivocal. For other infections, such as influenza and
Ebola virus, promising observational studies were not reliably confirmed by controlled
trials. In multiple infections, use of convalescent plasma has been distinguished by its
safety profile but not by the consistency of its benefit.

The current double-blind, placebo-controlled randomized clinical trial (RCT) is designed to
determine definitively whether this intervention is effective in a population at high risk of
complications and death from SARS-CoV-2 infection. The investigators compare the effect of
convalescent plasma vs. saline placebo with a robust study design, adequate sample size and
statistical and logistical rigor to assure that the interventions the investigators make to
treat serious disease are well-validated to support its use or to move on to test other
potentially safe and effective treatments.

This study is taking place at approximately 25 Veterans Affairs (VA) Medical Centers located
across the US. A participant's involvement will last up to 33 days. The entire study, from
the date the first person enters until the last participant is seen, is expected to last
about 20 months.

Data collected for this study will be analyzed and stored at the Palo Alto Cooperative
Studies Program Coordinating Center (CSPCC). After the study is completed, the de-identified,
archived data will continue to be stored at the Palo Alto CSPCC, accessible for use by
researchers including those outside of the study with an approved Data Use Agreement. The
biospecimens collected in the study for current and future research will be kept at the VA
Biorepository in Palo Alto, California unless otherwise specified. The biospecimens will be
accessible for future research with an approved Sample Use Agreement. The VA Central
Institutional Review Board (CIRB) will oversee the biorepository for this study. All samples
will be destroyed by standard practice within 20 years of study completion. Sample
destruction will be validated according to the Standard Operating Procedures of the VA
Biorepository.