Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

COVID-19 Convalescent Plasma (CCP) Transfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412486
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborator:
University of Mississippi Medical Center
Information provided by (Responsible Party):
Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center

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 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: COVID Convalescent Plasma Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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 Name: CCP, COVID-19 Convalescent Plasma




Primary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Length of ICU/hospital stay. [ Time Frame: Days 1, 3, 7, and 28 ]
    Total length of stay in ICU/hospital.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412486


Contacts
Layout table for location contacts
Contact: Gailen D Marshall, Jr., MD, PhD 601-815-5527 gmarshall@umc.edu

Locations
Layout table for location information
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gailen D Marshall, Jr., MD, PhD    601-815-5527    gmarshall@umc.edu   
Principal Investigator: Gailen D Marshall, Jr., MD, PhD         
Sub-Investigator: Utsav Nandi, MD         
Sub-Investigator: Lucar Lloveras, MD         
Sub-Investigator: Vishnu Garla, MD         
Sponsors and Collaborators
Gailen D. Marshall Jr., MD PhD
University of Mississippi Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Gailen D Marshall, Jr., MD, PhD University of Mississippi Medical Center
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Gailen D. Marshall Jr., MD PhD, Vice Chair for Research, Department of Medicine; Director, Division of Allergy, Asthma and Clinical Immunology, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT04412486    
Other Study ID Numbers: 2020-0137
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gailen D. Marshall Jr., MD PhD, University of Mississippi Medical Center:
COVID-19 Convalescent Plasma
Coronavirus
SARS-CoV-2