COVID-19 Convalescent Plasma (CCP) Transfusion

Overview

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 Title of Study: “An Open Label Trial of Transfusion of COVID-19 Convalescent Plasma (CCP) to Patients With Moderate to Severe COVID-19″

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 31, 2022

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.

Interventions

  • Biological: COVID Convalescent Plasma
    • One unit of COVID Convalescent Plasma transfused on Day 0

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gailen D. Marshall Jr., MD PhD
  • Collaborator
    • University of Mississippi Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: 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
  • Overall Official(s)
    • Gailen D Marshall, Jr., MD, PhD, Principal Investigator, University of Mississippi Medical Center
  • Overall Contact(s)
    • Gailen D Marshall, Jr., MD, PhD, 601-815-5527, gmarshall@umc.edu

References

Syal K. COVID-19: Herd Immunity and Convalescent Plasma Transfer Therapy. J Med Virol. 2020 Apr 13. doi: 10.1002/jmv.25870. [Epub ahead of print]

Xu Z, Li S, Tian S, Li H, Kong LQ. Full spectrum of COVID-19 severity still being depicted. Lancet. 2020 Mar 21;395(10228):947-948. doi: 10.1016/S0140-6736(20)30308-1. Epub 2020 Feb 14.

Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. Epub 2006 Aug 29.

Wong SS, Yuen KY. The management of coronavirus infections with particular reference to SARS. J Antimicrob Chemother. 2008 Sep;62(3):437-41. doi: 10.1093/jac/dkn243. Epub 2008 Jun 18. Review.

Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. Epub 2016 Sep 1. Review.

van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

Ye Q, Wang B, Mao J. The pathogenesis and treatment of the `Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10. Review.

Jiang S, Hillyer C, Du L. Neutralizing Antibodies against SARS-CoV-2 and Other Human Coronaviruses. Trends Immunol. 2020 May;41(5):355-359. doi: 10.1016/j.it.2020.03.007. Epub 2020 Apr 2. Erratum in: Trends Immunol. 2020 Apr 24;:.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.