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Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

COVID-19 Clinical Trial

Official title:
Phase II Randomized Study of Convalescent Plasma From Recovered COVID-19 Donors Collected by Plasmapheresis as Treatment for Subjects With Early COVID-19 Infection

Clinical Trial Summary

- This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Clinical Trial Description

Overall study design - This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications. - Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first. - Subjects will be randomized to receiving convalescent plasma or best supportive care. - Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease. - The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study. A total of 306 subjects will be recruited, 153 for each arm. If a patient in the best supportive care arm requires hospitalization, the patient will be eligible to receive convalescent plasma if requested and/or deemed medically appropriate by the admitting physician. Overall study duration - The study begins when the first subject (donor or recipient) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient). - The expected duration of the study is approximately 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04456413
Study type Interventional
Source Hackensack Meridian Health
Contact
Status Terminated
Phase Phase 2
Start date November 6, 2020
Completion date May 4, 2021
View Details
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