Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
Condition: COVID-19; Sars-CoV2
MeSH terms: COVID-19
Intervention: COVID-19 Convalescent Plasma (CCP); Placebo
Intervention description: COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.; Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects enrolled in the study will be randomized using a web based randomization procedure to receive convalescent plasma versus non-immune plasma at a 1:1 ratio.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Study investigators analyzing the data and participants will be blinded to the randomization. It may not be feasible to blind nursing staff to the treatment assignment to ensure proper ABO checking of the plasma unit at bedside per standard transfusion procedures, but every effort will be made to preserve blinding of the investigators, participant, and primary team providing care. An unblinded research assistant who is not involved in other aspects of the study will randomize the participant once enrolled. Randomization will be provided to an unblinded provider who is not part of the care team who will place the order for the plasma (CCP vs. control plasma) using a paper order that will not be part of the electronic medical record. The safety monitoring committee (SMC) will review study data, including unblinded data, to evaluate the safety, efficacy, study progress, and conduct of the study.
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; Sars-CoV2; Convalescent plasma

Summary:

      The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent
      plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset
      of initial symptoms.
    

Eligibility criteria:

        Inclusion Criteria for Enrollment:

          1. Patients ≥18 years of age

          2. Hospitalized with COVID-19

          3. Enrolled within 72 hours of hospitalization OR within day 14 from first signs of
             illness

          4. Pulmonary infiltrates on chest imaging

          5. Oxygenation of <95% on room air

          6. Laboratory confirmed COVID-19

        Exclusion Criteria

          1. Contraindication to transfusion due to inability to tolerate additional fluid, such as
             due to decompensated congestive heart failure

          2. Baseline requirement for oxygen supplementation prior to COVID-19 infection or use of
             positive pressure therapy for sleep disordered breathing

          3. Currently experiencing severe hypoxemic failure, as defined in study endpoints

          4. Prior receipt of plasma products, IVIG, or hyperimmune globulin within past 3 months

          5. Not currently enrolled another interventional clinical trial of COVID-19 treatment.

        Note: If taking medications with potential anti-COVID activity for the purpose of COVID-19
        treatment that do not yet have data to support efficacy, such as IL-6 antagonists, these
        medications must be stopped prior to enrollment. Receipt of current standard of care
        COVID-19 treatment, including remdesivir and dexamethasone is permitted and should be
        recorded as a concomitant medication.

        Note: Pregnancy is not exclusionary but will merit additional discussion of risks &
        benefits in the context of ongoing pregnancy