COVID-19 Convalescent Plasma (CCP) Transfusion

Gailen D. Marshall Jr., MD PhD

Status and phase: Completed; Early Phase 1

Conditions: COVID-19

Treatments: Biological: COVID Convalescent Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04412486

2020-0137

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Experimental group

Description:

Transfusion of COVID-19 convalescent plasma to participants with serious or life threatening complications from COVID-19 or are at high risk to develop serious complications.

Treatment:

Biological: COVID Convalescent Plasma