Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
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- STATUS
- Recruiting
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- End date
- Jan 31, 2023
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- participants needed
- 1344
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- sponsor
- Johns Hopkins University
Summary
To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.
Description
The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified 50:50 in the <65 vs 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.
Details
| Condition | SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, SARS-CoV 2, Sars Cov 2 |
|---|---|
| Treatment | SARS-CoV-2 convalescent plasma, Plasma from a volunteer donor |
| Clinical Study Identifier | NCT04373460 |
| Sponsor | Johns Hopkins University |
| Last Modified on | 29 January 2021 |
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