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 recovered from COVID-19 with high antibody levels to the CoV-2 virus will donate plasma at a Mississippi Blood Services facility. Recipients with COIVD-19 who have severe or life threatening conditions will receive plasma from those persons who have recovered from COVID-19.
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 infection with high titers of IgG antibody to this virus transfused into patients
with severe or at high risk of progressing to severe coronavirus-induced disease (COVID-19).
The research hypothesis is that COVID-19 convalescent plasma (CCP) transfusion improves
outcomes in patients with COVID-19.
The use of CCP to treat serious and life threatening COVID-19 has a sound biological as well
as clinical rationale to provide virus-specific immune protection in patients unable to
produce and/or maintain antiviral antibodies. This treatment protocol is designed primarily
to offer a rescue therapy in patients with severe and life threatening disease and explore
use in patients for whom a progression to serious disease is likely. Examining the specific
antibody responses to the virus in transfused patients if/when they show signs of recovery
and comparing these values with those obtained before the transfusion may provide information
to design more extensive trials aimed at identifying the best patient population for future
use of CCP.
Biological: COVID Convalescent Plasma
One unit of COVID Convalescent Plasma transfused on Day 0
Other Name: CCP, COVID-19 Convalescent Plasma
Inclusion Criteria:
1. Age ≥ 18
2. Clinician judged serious or life threatening COVID-19 (or at significant risk to
develop serious COVID) manifested by at least one of the following:
1. Laboratory confirmed diagnosis of SARS-CoV-2 infection
2. Hypoxia (PaO2/FiO2 <300, Pulse oximetry <93% at rest
3. Evidence of pulmonary infiltration
4. Respiratory failure
5. Sepsis
6. Multiple organ dysfunction or failure (assessed by SOFA score)
3. Informed consent provided by the patient or legally authorized representative (LAR)
Exclusion Criteria:
1. Greater than 21 days from confirmed COVID-19 diagnosis
2. Receipt of pooled immunoglobulin transfusion in previous 28 days
3. History of prior reaction to transfused blood products
4. Currently enrolled in other drug trials that preclude investigational treatment with
CoV-2 convalescent plasma transfusion
University of Mississippi Medical Center
Jackson, Mississippi, United States
Investigator: Gailen D Marshall, Jr., MD, PhD
Contact: 601-815-5527
gmarshall@umc.edu
Investigator:
Gailen D Marshall, Jr., MD, PhD
601-815-5527
gmarshall@umc.edu
Gailen D Marshall, Jr., MD, PhD, Principal Investigator
University of Mississippi Medical Center