COVID-19 Clinical Trial
Official title:
Convalescent Plasma for the Treatment of Patients With COVID-19
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.
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-exemptio
n-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.
;
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