Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
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ClinicalTrials.gov Identifier: NCT04420988
Expanded Access Status :
First Posted : June 9, 2020
Last Update Posted : August 2, 2021
Rutgers, The State University of New Jersey
University Hospital - Newark, NJ
Information provided by (Responsible Party):
Marc Klapholz, M.D., Rutgers, The State University of New Jersey
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
Condition or disease
COVID-19SARS-CoV 2SARS-CoV Infection
Biological: COVID-19 Convalescent Plasma
This expanded access program provides hospitalized patients who are severely or life-threateningly ill with COVID-19 access to investigational COVID-19 convalescent plasma (CCP). A clinical team comprised of Infectious Disease specialists, Pulmonary/Critical Care specialists and Hospitalists identify appropriate patients in accordance with FDA recommendations for patient eligibility and the daily availability of ABO-compatible CCP. CCP is obtained through New York Blood Center and American Red Cross in coordination with the University Hospital Blood Bank. Safety outcomes include monitoring for transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO) and any allergic reactions.Patients admitted to our institution prior to the availability of CCP will be separately reviewed.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Laboratory confirmed COVID-19.
Severe or life-threatening COVID-19. a) Severe disease is defined as one or more of the following: i) dyspnea, ii) respiratory frequency ≥ 30/min, iii) blood oxygen saturation ≤ 93%, iv) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or v) lung infiltrates > 50% within 24 to 48 hours b) Life-threatening disease is defined as one or more of the following: i) respiratory failure, ii) septic shock, and/or iii) multiple organ dysfunction or failure
Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products)
Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents
Other documented uncontrolled infection
Severe DIC needing factor replacement, FFP, cryoprecipitate