drugset / Trial / NCT04425837

Effectiveness and Safety of Convalescent Plasma in Patients With High-risk COVID-19

NCT04425837 ↗

Phase 2/3 Unknown 236 enrolled Fundación Santa Fe de Bogota
RandomizedParallel-groupSingle-blindTreatment

Summary

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected the global population with significant morbidity and mortality. One of the main concerns is the management of the patients since there is no specific treatment for this condition. Therefore, in SARS-CoV-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. This treatment has been used in other pandemics like SARS-CoV-1, H5N1, H1N1, Ebola, among others. This study is a phase II/III randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk SARS-CoV-2.

Timeline

Start
2020-07
Primary completion
2021-02
Completion
2021-02

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-SARS-CoV-2 convalescent plasma Protein / enzyme biologic 400 ml Intravenous

Indications