Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients
Condition: COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This randomized, double-blinded, phase 2 trial will assess the efficacy and safety of
      anti-SARS-CoV-2 convalescent plasma in hospitalized patients with less than 8 days of
      symptoms. Eligible participants will receive institutional-guided standard-of-care (SOC) and
      ABO-compatible convalescent COVID-19 plasma (CCP). The CCP units will be tested for the
      presence of anti-SARS-CoV-2 antibodies and pre-assigned as high-titer (CCP1) or
      standard-titer (CCP2) in a 1:1 randomization. Participants and clinical investigators will be
      blinded to the CCP titer group identities.

      The investigators plan to enroll approximately 56 participants (28 in each group) at
      UNC-Chapel Hill. Participants will be randomized within 48 hours of admission to a COVID
      service and will receive convalescent plasma within 24 hours of randomization. At least two
      units of CCP will be transfused 4-24 hours apart on study Day 0. If available, a third unit
      may be administered. All participants will undergo a series of safety and efficacy
      assessments pre-, during, and post-transfusion. Samples for research will be collected on Day
      0 through Day 28, unless previously discharged. Additionally, after discharge, participants
      can provide longitudinal samples collected at 1, 3, and 6-month timepoints after the
      infusion.
    

Intervention name(s): High-titer Convalescent COVID-19 Plasma (CCP1); Standard-titer Convalescent COVID-19 plasma (CCP2)
Intervention type(s): Biological; Biological
Intervention description(s): 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.
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)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus; Infection; SARS-CoV-2; Randomized; Hospitalized; Plasma; Neutralizing; Antibody