VA CoronavirUs Research and Efficacy Studies-1

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

The purpose of this study is to determine if treatment with convalescent plasma improves the clinical outcomes of Veterans who are hospitalized and require supplemental oxygen due to COVID-19.

Key facts

Study ID

NCT04539275

Run by

VA Office of Research and Development

People needed

75

Starts

2020-11-16

Expected to finish

2021-09-30

Last updated by the study team

2022-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veterans must meet all of the following criteria to be eligible to participate:
• Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2 infection.
• Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
• Participant (or legally authorized representative) understands and agrees to comply with planned study procedures.
• Veteran 18 years of age at time of screening.
• Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or antigen test, as documented by either of the following:
• (1)Reverse Transcription polymerase chain reaction (RT-PCR) or antigen positive (nasopharyngeal, oropharyngeal, saliva, lower respiratory) in sample collected 72 hours prior to screening; (2)RT-PCR or antigen positive in sample collected > 72 hours but 168 hours (i.e. 7 days) prior to screening, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc.), AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
• Requiring oxygen by nasal cannula or by face-mask as a new treatment (or if previously on home oxygen, at a liter flow at least 2 Lpm greater than home prescription), but not on humidified heated high-flow nasal cannula (HHHFNC) at 15 Lpm.
• Can be randomized within 72 hours of hospital admission. 8.Agrees not to participate in another therapeutic clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29 without approval from the investigator(s). Taking part in other research studies, including those unrelated to SARS-CoV-2, without first discussing it with the investigators of this study may invalidate the results of this study, as well as that of the other study.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Respiratory failure requiring mechanical ventilation, non-invasive ventilation including continuous positive airway pressure (CPAP) (for an indication other than previously diagnosed sleep apnea and maintained on outpatient settings), or extra-corporeal membrane oxygenation or anticipated to require any of those treatments or to die within 24 hours.
• Anticipated discharge from the hospital or transfer to another hospital that is not a study site within 72 hours.
• History of previous transfusion reaction.
• Previously documented serum immunoglobulin A (IgA) deficiency (<7 mg/dL)
• Documented to have received convalescent plasma in the last 60 days.

Where it is running

• Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States
• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
• North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
• Orlando VA Medical Center, Orlando, FL — Orlando, Florida, United States
• James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States
• John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States
• VA Southern Nevada Healthcare System, North Las Vegas, NV — North Las Vegas, Nevada, United States
• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
• Oklahoma City VA Medical Center, Oklahoma City, OK — Oklahoma City, Oklahoma, United States
• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• South Texas Health Care System, San Antonio, TX — San Antonio, Texas, United States
• VA Salt Lake City Health Care System, Salt Lake City, UT — Salt Lake City, Utah, United States
• Hunter Holmes McGuire VA Medical Center, Richmond, VA — Richmond, Virginia, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States
• VA Caribbean Healthcare System, San Juan, PR — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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