Phase 2
N=180
Convalescent Plasma to Stem Coronavirus (CSSC-001)
Coronavirus · Convalescence
Bottom Line
View on ClinicalTrials.gov: NCT04323800 ↗Enrolled (actual)
180
Serious AEs
10.7%
Results posted
Apr 2022
Primary outcome: Primary: Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection — 12; 13 Participants — p=0.42
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anti- SARS-CoV-2 Plasma (Biological); SARS-CoV-2 non-immune Plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Treatment at Day 28 as Assessed by Number of Participants Who Develop SARS-Cov-2 Infection |
12; 13 | 0.42 |
| PRIMARY Safety of Treatment With High-titer Anti- SARS-CoV-2 Plasma Versus Control as Assessed by Number of Participants With "Serious Adverse Events" |
0; 1 | 0.67 |
| PRIMARY 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 |
23; 70 | 0.06 |
| SECONDARY Number of Participants With Severe Disease |
0; 2 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04323800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.