drugset / Trial / NCT04816942

Clinical Efficacy of Early Administration of Convalescent Plasma Among COVID-19 Cases in Egypt

NCT04816942

Phase 3 Completed 102 enrolled Ministry of Health and Population, Egypt
NaSingle-groupOpen-labelTreatment

Summary

One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19 (Refs. 1-4). Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARSCoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic (Refs. 5-7). Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID19 convalescent plasma in clinical trials. This guidance provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. This guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma..

Timeline

Start
2020-04-23
Primary completion
2020-07-21
Completion
2020-10-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent Plasma Protein / enzyme biologic 400 ml