Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-01 @ 9:10 AM
Study NCT ID:
NCT04372368
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-08-28
First Post:
2020-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Convalescent Plasma for the Treatment of Patients With COVID-19
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Convalescent Plasma for the Treatment of Patients With COVID-19
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This expanded access program will provide access to COVID-19 convalescent plasma 150 or more individuals with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations at participating hospitals in Colorado.COVID-19 convalescent plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19.
Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.
Convalescent plasma collected from individuals who have recovered from COVID-19 contains antibodies to SARS-CoV-2. Preliminary evidence and data collected during other respiratory virus outbreaks (including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic) suggest that the antibodies in convalescent plasma may be effective in fighting the infection.
Detailed Description:
COVID-19 convalescent plasma will be obtained from FDA registered blood banks and will meet all regulatory requirements for conventional plasma and FDA's additional considerations for COVID-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).
The primary objective of this expanded access program is to provide COVID-19 convalescent plasma to patients with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations.
The secondary objective will be the evaluation of safety, as assessed by incidents of adverse events judged by the treating physician to be potentially related to the administration of COVID-19 convalescent plasma.
Exploratory objectives will include assessments for antibody responses for patients that receive convalescent plasma. An exploratory analysis may be conducted correlating the level of neutralizing antibody titers with clinical outcomes observed. Due to the need to monitoring COVID19 antibody responses following infusion, blood testing at day 1 post-treatment and at discharge will be obtained as part of enrollment.
The primary objective of this expanded access program is to provide COVID-19 convalescent plasma to patients with moderate to severe or life-threatening manifestations of COVID-19, or documented to be at high risk of developing such manifestations.
The secondary objective will be the evaluation of safety, as assessed by incidents of adverse events judged by the treating physician to be potentially related to the administration of COVID-19 convalescent plasma.
Exploratory objectives will include assessments for antibody responses for patients that receive convalescent plasma. An exploratory analysis may be conducted correlating the level of neutralizing antibody titers with clinical outcomes observed. Due to the need to monitoring COVID19 antibody responses following infusion, blood testing at day 1 post-treatment and at discharge will be obtained as part of enrollment.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: