Convalescent Plasma to Stem Coronavirus (CSSC-001)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Coronavirus, Convalescence

Intervention / Treatment
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* Biological: Anti- SARS-CoV-2 Plasma
* Biological: SARS-CoV-2 non-immune Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must be 18 years of age or older 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 Receipt of any blood product in past 120 days. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. Laboratory evidence of COVID-19 infection at time of screening. History or known laboratory evidence of previous COVID-19 infection. History of prior reactions to transfusion blood products. Inability to complete therapy with the study product within 24 hours after randomization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 ratio
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High titer anti-SARS-CoV-2 plasma<br>Participants with High titer anti-SARS-CoV-2 plasma. | Biological: Anti- SARS-CoV-2 Plasma<br>* 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<br>|
| Active Comparator: SARS-CoV-2 non-immune plasma<br>Participants with SARS-CoV-2 non-immune plasma. | Biological: SARS-CoV-2 non-immune Plasma<br>* Normal human plasma collected prior to December 2019<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection | 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. | Day 28 | 
| Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With Serious Adverse Events | Number of participants with serious adverse events categorized as either severe infusion reactions or Acute Respiratory Distress Syndrome during the study period. | Up to Day 28 | 
| 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 | 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. | Up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Severe Disease | 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 | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19