Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04542967
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2020-09-04
Brief Title:
Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease
Sponsor:
Hospital Central Militar
Organization:
Hospital Central Militar
Study Overview
Official Title:
Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease
Status:
COMPLETED
Status Verified Date:
2020-09
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:
PC-COVID-HCM
Brief Summary:
Currently there is no specific treatment or vaccine for SARS-CoV-2 available some drugs are being investigated as treatment but the effect is unknown A strategy and other method used before in coronavirus pandemic SARS-CoV in 2003 and MERS-CoV in 2012 was the use of immune convalescent plasma Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease This research proposes the passive administration of antibodies through the transfusion of convalescent plasma in patients with severe COVID-19 disease
Detailed Description:
A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease Patients will be randomized 11 in a single blind study The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate Our primary outcomes will be disease progression and mortality evaluate of ordinal Scale for Clinical Improvement and WHO
Study Oversight
Has Oversight DMC:
None
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?:
None