Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients
Condition: COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Intervention: High-titer Convalescent COVID-19 Plasma (CCP1); Standard-titer Convalescent COVID-19 plasma (CCP2)
Intervention description: At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.; At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has 2 treatment arms and participants will be assigned/randomized to one arm:
CCP1 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned high-titer
CCP2 - CCP tested for the presence of anti-SARS-CoV-2 antibodies and assigned standard-titer
Masking: Double (Participant, Investigator)
Masking description: This study is double-blinded so neither the participant nor the study team/investigators will know which plasma treatment (CCP1 or CCP2) that the participant is receiving.
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: COVID-19; Coronavirus; Infection; SARS-CoV-2; Randomized; Hospitalized; Plasma; Neutralizing; Antibody

Summary:

      The purpose of this research study is to find out if CCP is safe and to determine the safest
      and most effective level of anti-viral antibody when given to people admitted to the hospital
      with confirmed COVID-19 infection. Participants enrolled on this study will be transfused
      with 2 units of CCP through an IV. These units will be given one at a time 4 to 24 hours
      apart. Participants will be randomized to receive either 2 units with standard antibody
      levels as recommended by the FDA or 2 units with an antibody level higher than that
      recommended by the FDA. This study is experimental and CCP is investigational and has not
      been approved by the FDA for the treatment of COVID-19. The CCP is collected per FDA
      guidelines from persons recovered from COVID-19 infection. The plasma contains antibodies and
      possibly other properties that inhibit the virus. The investigators do not know if the level
      of antibodies present in the CCP will make a difference in how the participant's body is able
      to fight the infection and hope to learn that in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age at least 18 years

          2. Ability and willingness of participant or Legally Authorized Representative (LAR) to
             give written informed consent.

          3. Laboratory confirmed diagnosis of infection with SARS-CoV-2 by PCR

          4. Hospitalized for COVID-19 with one or more respiratory or gastrointestinal (GI)
             symptoms:

               -  COVID-19 associated respiratory symptoms include but are not limited to: cough,
                  shortness of breath, difficulty breathing, or sore throat

               -  COVID-19 associated GI symptoms include but are not limited to: loss of taste,
                  loss of sense of smell, diarrhea, nausea, or vomiting,

        Note: Respiratory and GI symptoms other than those listed above, must be noted as
        acceptable and signed by study PI or designee.

        Exclusion Criteria:

          1. Receipt of pooled immunoglobulin in past 30 days

          2. Current or prior enrollment in a SARS-CoV-2 antibody or T-cell therapeutic study.

             Note: Patients enrolled on other randomized controlled trials of pharmaceutical and/or
             non-pharmaceutical interventions for COVID and meeting eligibility criteria will not
             be excluded, as determined by study PI (or designee) on a case-by-case basis and as
             allowed by eligibility criteria of the other trials.

          3. Contraindication to transfusion or history of prior reactions to transfusion blood
             products. This may include religious or cultural objections to receiving blood
             products and transfusions.

          4. ABO-compatible titered plasma is not available

          5. > 10 days from noted COVID-related subjective or objective fever at randomization.
             Patients without subjective or objective fever, > 10 days from symptom onset as
             determined by study PI.