COVID-19 Convalescent Plasma (CCP) Transfusion

November 28, 2023 updated by: Gailen D. Marshall Jr., MD PhD

An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gailen D Marshall, Jr., MD, PHD
  • Phone Number: 601-815-5527
  • Email: gmarshall@umc.edu

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion
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.
Biological: COVID Convalescent Plasma
One unit of COVID Convalescent Plasma transfused on Day 0
Other Names:
  • CCP, COVID-19 Convalescent Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in PaO2/FiO2 after CCP transfusion.
Time Frame: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by PaO2/FiO2.
3 Days
Change in pulse oximetry status after CCP transfusion.
Time Frame: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by pulse oximetry.
3 Days
Change in aO2 after CCP transfusion.
Time Frame: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by aO2.
3 Days
Change in respiratory rate after CCP transfusion.
Time Frame: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by respiratory rate.
3 Days
Change in intubation status after CCP transfusion.
Time Frame: 3 Days
Change in pre-transfusion respiratory status compared to Day 3 respiratory status measured by intubation status.
3 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sequential Organ Failure Assessment (SOFA).
Time Frame: Days 1, 3, 7, and 28
Change in SOFA score pre-transfusion to Days 1, 3, 7, and 28 post-transfusion.
Days 1, 3, 7, and 28
Change in 8-point ordinal clinical deterioration scale.
Time Frame: Days 1, 3, 7, and 28
Change in 8-point ordinal clinical deterioration scale pre-transfusion to Days 1, 3, 7, and 28 post-transfusion. The 8-point ordinal scale measured by: 8-death, 7-ventilation in addition to ECMO, CRRT and/or vasopressor; 6-intubation and mechanical ventilation; 5-non-invasive mechanical ventilation or high flow oxygen 4- supplemental oxygen by mask or nasal cannula; 3- hospitalization without supplemental oxygen; 2- limitation of activities and 1- no limitation of activities, discharge from hospital.
Days 1, 3, 7, and 28
Length of ICU/hospital stay.
Time Frame: Days 1, 3, 7, and 28
Total length of stay in ICU/hospital.
Days 1, 3, 7, and 28
Development of plasma transfusion reactions.
Time Frame: Days 1, 3, 7, and 28
Presence of any signs or symptoms of plasma transfusion reactions at Days 1, 3, 7, and 28 post-transfusion.
Days 1, 3, 7, and 28
Development of immune complex disorders.
Time Frame: Days 1, 3, 7, and 28
Presence of any signs or symptoms of immune complex disorders (fever spike, urticarial lesion, arthralgias, myalgias, hematuria, non IgE-mediated anaphylaxis) at Days 1, 3, 7, and 28 post-transfusion.
Days 1, 3, 7, and 28
Change in anti CoV-2 IgM and IgG levels.
Time Frame: Days 1, 3, 7, and 28
Change in anti CoV-2 IgM and IgG levels pre-transfusion compared to levels on Days 1, 3, 7, and 28 post-transfusion.
Days 1, 3, 7, and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gailen D. Marshall Jr., MD PhD

Collaborators

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Gailen D Marshall, Jr., MD, PhD, University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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