Viewing Study NCT04344535


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Ignite Modification Date: 2025-12-24 @ 10:19 PM
Study NCT ID: NCT04344535
Status: TERMINATED
Last Update Posted: 2021-12-06
First Post: 2020-04-10
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Convalescent Plasma vs. Standard Plasma for COVID-19
Sponsor: Stony Brook University
Organization:

Study Overview

Official Title: Convalescent Plasma to Reduce Complications Associated With COVID-19 Infection: A Randomized Trial Comparing the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma vs. Standard Plasma in Hospitalized Patients With COVID- 19 Infection
Status: TERMINATED
Status Verified Date: 2021-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Insufficient eligible and consenting patients
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to find out if transfusion of blood plasma containing antibodies against COVID-19 (anti-SARS-CoV-2), which were donated from a patient who recovered from COVID-19 infection, is safe and can treat COVID-19 in hospitalized patients.

Antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. Transferring plasma from a person who recovered from COVID-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.
Detailed Description: None

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?: