Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT04343261
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2020-04-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Convalescent Plasma in the Treatment of COVID 19
Sponsor:
Trinity Health Of New England
Organization:
Study Overview
Official Title:
Convalescent Plasma in the Treatment of COVID 19
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:
None
Brief Summary:
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Detailed Description:
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19.
1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.
2\. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19.
2\. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: