VA CoronavirUs Research and Efficacy Studies-1
Condition: COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Convalescent Plasma; Masked Saline Placebo
Intervention description: Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.; 0.9% saline solution will be used as the Masked Saline Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two study treatment arms: convalescent plasma versus saline. Participants will be randomized in 1:1 ratio to these two arms.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The participants, site investigators, clinical prescribers, site coordinators, and most other individuals involved in this study will be blinded to the treatment assignment.
Furthermore, the blind will not routinely be broken in order to select post-study, pharmacologic treatment for SARS-CoV-2 infection administered by clinical healthcare providers.
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 2019 novel coronavirus disease; COVID-19 pandemic; COVID-19 virus infection; COVID-19 virus disease; Respiratory failure; Pneumonia, viral / therapy; Blood Component Transfusion; Severity of Illness Index; Survival Analysis; Treatment Outcome; Prospective Study; Humans; Adults; Male; Female; convalescent plasma; SARS CoV-2; COVID-19 convalescent plasma

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Veterans must meet all of the following criteria to be eligible to participate:

          1. Admitted to a participating VA clinical site with symptoms suggestive of SARS-CoV-2
             infection.

          2. Participant (or legally authorized representative) provides informed consent prior to
             initiation of any study procedures.

          3. Participant (or legally authorized representative) understands and agrees to comply
             with planned study procedures.

          4. Veteran 18 years of age at time of screening.

          5. 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.

        6.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.

        7.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.

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. 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.

          2. Anticipated discharge from the hospital or transfer to another hospital that is not a
             study site within 72 hours.

          3. History of previous transfusion reaction.

          4. Previously documented serum immunoglobulin A (IgA) deficiency (<7 mg/dL)

          5. Documented to have received convalescent plasma in the last 60 days.