Phase 2
N=48
Convalescent Plasma in the Treatment of COVID 19
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) · COVID · Coronavirus
Bottom Line
View on ClinicalTrials.gov: NCT04343261 ↗Enrolled (actual)
48
Serious AEs
16.7%
Results posted
Sep 2020
Primary outcome: Primary: Mortality — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Convalescent Plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trinity Health Of New England
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
19 | — |
| PRIMARY Viral Load |
3524; 2033; 315; 494 | — |
| PRIMARY Serum Antibody Titers |
18.5; 37.2; 47.4; 55.2 | — |
Summary
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Eligibility Criteria
Inclusion Criteria
- All genders
- Age > 18 yrs and 50% within 24 to 48 hours
Life-threatening disease is defined as:
- respiratory failure,
- septic shock
- multiple organ dysfunction or failure
Exclusion Criteria
- No gender exclusion
- Age 90 yrs
- COVID-19 negative
Data sourced from ClinicalTrials.gov (NCT04343261). 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.