COVID-19 Clinical Trial
Official title:
Investigational COVID-19 Convalescent Plasma Infusion for Severely or Life-threateningly Ill COVID-19 Patients
NCT number | NCT04420988 |
Other study ID # | Pro2020000746, Pro2020000911 |
Secondary ID | |
Status | No longer available |
Phase | |
First received | |
Last updated |
Verified date | November 2023 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
This is an expanded access program providing COVID-19 convalescent plasma to patients hospitalized with severely or life-threateningly ill COVID-19.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Laboratory confirmed COVID-19. 2. 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 Criteria: 1. Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products) 2. Severe multi-organ failure and hemodynamic instability requiring high doses of pressor agents 3. Other documented uncontrolled infection 4. Severe DIC needing factor replacement, FFP, cryoprecipitate 5. Acute renal failure requiring dialysis 6. Active intracranial bleeding 7. Clinically significant myocardial ischemia |
Country | Name | City | State |
---|---|---|---|
United States | Rutgers New Jersey Medical School | Newark | New Jersey |
United States | University Hospital | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | University Hospital - Newark, NJ |
United States,
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* Note: There are 16 references in all — Click here to view all references
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