Status:
NO_LONGER_AVAILABLE
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
University Hospital - Newark, NJ
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Brief Summary
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
Detailed Description
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 compr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04420988
Last Update
November 28 2023
Active Locations (2)
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1
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
2
University Hospital
Newark, New Jersey, United States, 07103