Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
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ClinicalTrials.gov Identifier: NCT04445207
Expanded Access Status :
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Information provided by (Responsible Party):
Jonathan Gerber, University of Massachusetts, Worcester
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
Condition or disease
COVIDSars-CoV2Corona Virus Infection
Biological: Convalescent Plasma
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.
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Layout table for eligibility information
Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
At least 12 years of age
Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
Severe COVID-19 is defined by one or more of the following:
Respiratory frequency ≥ 30/min
Blood oxygen saturation ≤ 93%
Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
Lung infiltrates > 50% within 24-48 hours
Life-threatening COVID-19 is defined as one or more of the following:
Multiple organ dysfunction or failure
History of prior life-threatening reactions to transfusion of blood products
Not receiving other therapies that would preclude plasma transfusion