Viewing Study NCT04332835


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Study NCT ID: NCT04332835
Status: COMPLETED
Last Update Posted: 2020-11-27
First Post: 2020-03-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Sponsor: Universidad del Rosario
Organization:

Study Overview

Official Title: Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Status: COMPLETED
Status Verified Date: 2020-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CP-COVID-19
Brief Summary: Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks
Detailed Description: The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: