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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

Tracking Information
First Submitted Date  ICMJE March 24, 2020
First Posted Date  ICMJE March 27, 2020
Last Update Posted Date November 9, 2020
Actual Study Start Date  ICMJE June 10, 2020
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
Cumulative incidence of composite outcome of disease severity [ Time Frame: Day 28 ]
The cumulative incidence of composite outcome of disease severity will be used in assessing the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to COVID-19. This will be determined with the presence or occurrence of at least one of the following:
  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
  6. Not hospitalized, no clinical evidence of COVID-19 infection, but with positive PCR for SARS-CoV-2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2020)
  • Anti-SARS-CoV-2 titers [ Time Frame: Baseline ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 0 (baseline).
  • Anti-SARS-CoV-2 titers [ 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.
  • Anti-SARS-CoV-2 titers [ Time Frame: Day 3 ]
    Compare the anti-SARS-CoV-2 convalescent plasma and control (SARS-CoV-2 non-immune plasma) groups anti-SARS-CoV-2 titers at day 3.
  • Anti-SARS-CoV-2 titers [ 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.
  • Anti-SARS-CoV-2 titers [ 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.
  • Anti-SARS-CoV-2 titers [ 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.
  • 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.
  • 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.
  • Peak quantity levels of SARS-CoV-2 RNA [ Time Frame: Up to day 14 ]
    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, 7, 14 days.
Current Other Pre-specified Outcome Measures
 (submitted: July 15, 2020)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Convalescent Plasma to Stem Coronavirus (CSSC-001)
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus
  • Convalescence
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: High titer anti-SARS-CoV-2 plasma
    Participants with High titer anti-SARS-CoV-2 plasma.
    Intervention: Biological: Anti- SARS-CoV-2 Plasma
  • Active Comparator: SARS-CoV-2 non-immune plasma
    Participants with SARS-CoV-2 non-immune plasma.
    Intervention: Biological: SARS-CoV-2 non-immune Plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
500
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2020)
150
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shmuel Shoham, MD 410-614-6702 TOID_CRC@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04323800
Other Study ID Numbers  ICMJE IRB00245634
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Sharing is governed by Johns Hopkins University Institutional Guidelines
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shmuel Shoham, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP