Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients

NO_LONGER_AVAILABLE

Conditions studied: COVID-19, SARS-CoV 2, SARS-CoV Infection

In brief

This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.

Key facts

Study ID

NCT04420988

Run by

Rutgers, The State University of New Jersey

Last updated by the study team

2023-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Acute renal failure requiring dialysis
• Active intracranial bleeding
• Clinically significant myocardial ischemia

Where it is running

• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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