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

• Conditions: COVID-19; SARS-CoV 2; SARS-CoV Infection

• Registration Number: NCT04420988
• Lead Sponsor: Rutgers, The State University of New Jersey

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 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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (2)

Rutgers New Jersey Medical School; 🇺🇸 Newark, New Jersey, United States

University Hospital; 🇺🇸 Newark, New Jersey, United States