Status:
COMPLETED
COVID-19 Convalescent Plasma (CCP) Transfusion
Lead Sponsor:
Gailen D. Marshall Jr., MD PhD
Collaborating Sponsors:
University of Mississippi Medical Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This research study evaluates the safety and effectiveness for the use of convalescent plasma transfusion as a treatment option for novel coronavirus SARS-CoV-2 infection (COVID-19). Donors who have r...
Detailed Description
The research purpose is to evaluate the safety and clinical effectiveness of transfusing one unit of banked plasma obtained from patients who have recovered from the novel coronavirus SARS-C0V-2 infec...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
- Laboratory confirmed diagnosis of SARS-CoV-2 infection
- Hypoxia (PaO2/FiO2 \<300, Pulse oximetry \<93% at rest
- Evidence of pulmonary infiltration
- Respiratory failure
- Sepsis
- Multiple organ dysfunction or failure (assessed by SOFA score)
- Informed consent provided by the patient or legally authorized representative (LAR)
Exclusion
- Greater than 21 days from confirmed COVID-19 diagnosis
- Receipt of pooled immunoglobulin transfusion in previous 28 days
- History of prior reaction to transfused blood products
- Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04412486
Start Date
June 1 2020
End Date
March 23 2023
Last Update
November 29 2023
Active Locations (1)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216