Convalescent Plasma to Stem Coronavirus (CSSC-001)

Overview

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Full Title of Study: “Convalescent Plasma to Stem Coronavirus: A Randomized, Blinded Phase 2 Study Comparing the Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: April 22, 2021

Detailed Description

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Interventions

• Biological: Anti- SARS-CoV-2 Plasma
  • SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
• Biological: SARS-CoV-2 non-immune Plasma
  • Normal human plasma collected prior to December 2019

Arms, Groups and Cohorts

• Experimental: High titer anti-SARS-CoV-2 plasma
  • Participants with High titer anti-SARS-CoV-2 plasma.
• Active Comparator: SARS-CoV-2 non-immune plasma
  • Participants with SARS-CoV-2 non-immune plasma.

Clinical Trial Outcome Measures

Primary Measures

• Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection
  • Time Frame: Day 28
  • Comparison of proportions of cumulative incidence of development of SARS-Cov-2 infection (symptoms compatible with infection and/or + molecular testing) regardless of disease severity, following high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19.
• Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With “Serious Adverse Events”
  • Time Frame: Up to Day 28
  • Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period.
• Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Cumulative Incidence of Grade 3 and 4 Adverse Events
  • Time Frame: Up to Day 28
  • Cumulative incidence of grade 3 and 4 adverse events during the study period evaluated as events per 100 person-years will be used to assess safety of the intervention.

Secondary Measures

• Number of Participants With Severe Disease
  • Time Frame: Up to 28 days
  • Number of participants with severe disease between the anti-SARS-CoV-2 convalescent plasma and control groups. Severity of disease will be measured using the number of participants with any of the disease severity categories below: Death Requiring mechanical ventilation and/or in ICU non-ICU hospitalization, requiring supplemental oxygen non-ICU hospitalization, not requiring supplemental oxygen

Participating in This Clinical Trial

Inclusion Criteria 1. Subjects must be 18 years of age or older 2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma) Exclusion Criteria 1. Receipt of any blood product in past 120 days. 2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. 3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. 4. Laboratory evidence of COVID-19 infection at time of screening. 5. History or known laboratory evidence of previous COVID-19 infection. 6. History of prior reactions to transfusion blood products. 7. Inability to complete therapy with the study product within 24 hours after randomization.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Johns Hopkins University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Shmuel Shoham, MD, Principal Investigator, Johns Hopkins University