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History of Changes for Study: NCT04323800
Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19 (CSSC-001)
Latest version (submitted April 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 26, 2020 None (earliest Version on record)
2 March 31, 2020 Contacts/Locations and Study Status
3 April 6, 2020 Contacts/Locations, Outcome Measures, Study Status, Sponsor/Collaborators, Study Identification and Eligibility
4 May 13, 2020 Study Status, Study Description and Study Identification
5 June 4, 2020 Study Status
6 June 18, 2020 Recruitment Status, Study Status, Oversight, Contacts/Locations and Eligibility
7 June 22, 2020 Contacts/Locations and Study Status
8 June 24, 2020 Contacts/Locations, Study Design and Study Status
9 July 13, 2020 Contacts/Locations and Study Status
10 July 14, 2020 Contacts/Locations and Study Status
11 July 14, 2020 Contacts/Locations and Study Status
12 July 15, 2020 Outcome Measures, Eligibility, Arms and Interventions, Study Design, Study Description and Study Status
13 August 7, 2020 Contacts/Locations, Eligibility and Study Status
14 August 13, 2020 Contacts/Locations and Study Status
15 August 26, 2020 Contacts/Locations and Study Status
16 September 11, 2020 Contacts/Locations and Study Status
17 October 8, 2020 Contacts/Locations and Study Status
18 October 19, 2020 Contacts/Locations and Study Status
19 November 6, 2020 Contacts/Locations and Study Status
20 March 30, 2021 Contacts/Locations and Study Status
21 March 31, 2021 Contacts/Locations and Study Status
22 April 6, 2021 Recruitment Status, Contacts/Locations and Study Status
23 March 9, 2022 Recruitment Status, Study Status and Study Design
24 April 20, 2022 Outcome Measures, Study Status, Document Section and Results
25 April 22, 2022 Outcome Measures, Adverse Events, Baseline Characteristics and Study Status
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Study NCT04323800
Submitted Date:  March 26, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: IRB00245634
Brief Title: Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19 (CSSC-001)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2020
Overall Status: Not yet recruiting
Study Start: April 1, 2020
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: January 2023 [Anticipated]
First Submitted: March 24, 2020
First Submitted that
Met QC Criteria:
March 26, 2020
First Posted: March 27, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
March 26, 2020
Last Update Posted: March 27, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Coronavirus
Convalescence
Keywords: COVID-19
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
1:1 ratio
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 was found to have a titer of neutralizing antibody >1:64)
Active Comparator: SARS-CoV-2 non-immune plasma
Participants with SARS-CoV-2 non-immune plasma.
Biological: SARS-CoV-2 non-immune Plasma
Standard plasma collected prior to December 2019
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Subjects must be 18 years of age or older
  • Close contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma)
  • If female must not be pregnant and/or breastfeeding. Women of childbearing potential and men, must be willing to practice an effective contraceptive method or remain abstinent during the study period.

    *Close contact* is defined by the Centers for Disease Control and Prevention (CDC) as:

    a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time (without PPE); close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case

  • or -

    b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on) without PPE

Exclusion Criteria:

  • Receipt any blood product in past 120 days
  • Psychiatric or 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
  • Nucleic acid testing evidence of COVID-19 infection at time of screening
  • History of prior reactions to transfusion blood products
  • Inability to complete therapy with the study product within 24 hours after enrollment
Open or close this module Contacts/Locations
Central Contact Person: Darin Ostrander, PhD
Telephone: 410-614-6702
Email: dostran1@jhmi.edu
Central Contact Backup: Obi Ezennia, MPH
Telephone: 410-614-6702
Email: oezenni1@jhmi.edu
Study Officials: Darin Ostrander, PhD
Study Director
Johns Hopkins University
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Sharing is governed by Johns Hopkins University Institutional Guidelines
Open or close this module References
Links:
Available IPD/Information:

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