Effects of COVID-19 Convalescent Plasma (CCP) on Coronavirus-associated Complications in Hospitalized Patients
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- STATUS
- Recruiting
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- participants needed
- 30
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- sponsor
- Priscilla Hsue, MD
Summary
The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.
Description
A total of 30 eligible subjects will be randomized in a 1:1 ratio to receive either convalescent fresh frozen plasma (frozen within 8 hours of collection) of PF24 (frozen within 24 hours) from blood donors who have recovered from COVID-19 containing antibodies to SARS-CoV-2 or control (standard fresh frozen plasma collected prior to 12/1/2019 or with documented negative SARS-CoV-2 antibody). Should additional anti-COVID agents (anti-viral and/or anti-inflammatory) become available for use as standard of care during implementation, the sample size will be recalculated and increased to account for the estimated impact that these agents may have on the reducing the progression to the primary endpoint of severe hypoxemia.
Details
| Condition | Covid 19, Sars-CoV2 |
|---|---|
| Age | 18-100 years |
| Treatment | Placebo, COVID-19 Convalescent Plasma (CCP) |
| Clinical Study Identifier | NCT04421404 |
| Sponsor | Priscilla Hsue, MD |
| Last Modified on | 19 February 2024 |
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