Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
Study NCT ID:
NCT04390503
Status:
TERMINATED
Last Update Posted:
2024-08-28
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Convalescent Plasma for Early Treatment of COVID-19
Sponsor:
Andrew Eisenberger
Organization:
Study Overview
Official Title:
A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.
Detailed Description:
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.
Study Oversight
Has Oversight DMC:
True
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?: