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Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)

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ClinicalTrials.gov Identifier: NCT04323800
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronavirus Convalescence Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : January 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: High titer anti-SARS-CoV-2 plasma
Participants with High titer anti-SARS-CoV-2 plasma.
 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
Active Comparator: SARS-CoV-2 non-immune plasma
Participants with SARS-CoV-2 non-immune plasma.
 Biological: SARS-CoV-2 non-immune Plasma
Normal human plasma collected prior to December 2019


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of treatment at Day 28 [ 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.

  2. Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 1 [ Time Frame: Up to Day 28 ]
    Cumulative incidence of serious adverse events categorized separately as either severe infusion reactions and Acute Respiratory Distress Syndrome during the study period.

  3. Safety of treatment with high-titer Anti- SARS-CoV-2 plasma versus control - 2 [ Time Frame: Up to Day 28 ]
    Cumulative incidence of grade 3 and 4 adverse events during the study period


Secondary Outcome Measures :
  1. Cumulative incidence of disease severity [ Time Frame: up to Day 28 ]

    Cumulative incidence of disease severity between the anti-SARS-CoV-2 convalescent plasma and control groups after individuals develop SARS-CoV-2 infection. Severity of disease will be measured using a clinical event scale of disease severity (evaluated up to Day 28):

    1. Death
    2. Requiring mechanical ventilation and/or in ICU
    3. non-ICU hospitalization, requiring supplemental oxygen;
    4. non-ICU hospitalization, not requiring supplemental oxygen;
    5. Not hospitalized, but with clinical and laboratory evidence of COVID-19 infection


Other Outcome Measures:
  1. Anti-SARS-CoV-2 titers Day 0 [ Time Frame: Day 0 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day -1 or day 0 (baseline).

  2. Anti-SARS-CoV-2 titers Day 1 [ Time Frame: Day 1 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 1.

  3. Anti-SARS-CoV-2 titers Day 7 [ Time Frame: Day 7 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 7.

  4. Anti-SARS-CoV-2 titers Day 14 [ Time Frame: Day 14 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 14.

  5. Anti-SARS-CoV-2 titers Day 90 [ Time Frame: Day 90 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups' anti-SARS-CoV-2 titers at day 90.

  6. Rates of SARS-CoV-2 PCR positivity [ Time Frame: Up to day 28 ]
    Compare the rates of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

  7. Duration of SARS-CoV-2 PCR positivity [ Time Frame: Up to day 28 ]
    Compare the duration (days) of SARS-CoV-2 PCR positivity (RT-PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 7, 14 and 28.

  8. Peak quantity levels of SARS-CoV-2 RNA [ Time Frame: Up to day 28 ]
    Compare the peak quantity levels of SARS-CoV-2 RNA amongst the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups at days 0, 1, 7, 14 and 28 days.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323800


Contacts
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Contact: Shmuel Shoham, MD 410-614-6702 TOID_CRC@jhmi.edu

Locations
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Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Shmuel Shoham, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04323800    
Other Study ID Numbers: IRB00245634
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing is governed by Johns Hopkins University Institutional Guidelines

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johns Hopkins University:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Convalescence
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Disease Attributes
Pathologic Processes