Convalescent Plasma to Stem Coronavirus (CSSC-001) (CSSC-001)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04323800|
Recruitment Status : Completed
First Posted : March 27, 2020
Results First Posted : April 22, 2022
Last Update Posted : April 26, 2022
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Convalescence||Biological: Anti- SARS-CoV-2 Plasma Biological: SARS-CoV-2 non-immune Plasma||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 ratio|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Primary Completion Date :||April 22, 2021|
|Actual Study Completion Date :||June 22, 2021|
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
- 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.
- 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:
- Requiring mechanical ventilation and/or in ICU
- non-ICU hospitalization, requiring supplemental oxygen
- non-ICU hospitalization, not requiring supplemental oxygen
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
|Principal Investigator:||Shmuel Shoham, MD||Johns Hopkins University|