Phase 2
N=30
Convalescent Plasma for Patients With COVID-19
Coronavirus Infection · Coronavirus · COVID
Bottom Line
View on ClinicalTrials.gov: NCT04385199 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Change in Respiratory Disease Severity — 251; 276 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Convalescent plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Respiratory Disease Severity |
251; 276 | — |
| SECONDARY ICU Length of Stay |
19.5; 13 | — |
| SECONDARY Length of Stay |
20; 11.5 | — |
| SECONDARY Ventilator Days |
15.6; 4.2 | — |
| SECONDARY Number of Participants With Transfusion Adverse Events |
0; 0 | — |
| SECONDARY Normal Chest X Ray at 28 Days |
9; 3 | — |
| SECONDARY All-cause Mortality |
3; 2 | — |
Summary
Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Eligibility Criteria
Inclusion Criteria
- age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours
Exclusion Criteria
- Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Data sourced from ClinicalTrials.gov (NCT04385199). 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.