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Completed

NCT Number: NCT04412486

COVID-19 Convalescent Plasma (CCP) Transfusion

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Clinician judged serious or life threatening COVID-19 (or at significant risk to develop serious COVID) manifested by at least one of the following:
  • Laboratory confirmed diagnosis of SARS-CoV-2 infection
  • Hypoxia (PaO2/FiO2 <300, Pulse oximetry <93% at rest
  • Evidence of pulmonary infiltration
  • Respiratory failure
  • Sepsis
  • Multiple organ dysfunction or failure (assessed by SOFA score)
  • Informed consent provided by the patient or legally authorized representative (LAR)

Exclusion criteria

  • Greater than 21 days from confirmed COVID-19 diagnosis
  • Receipt of pooled immunoglobulin transfusion in previous 28 days
  • History of prior reaction to transfused blood products
  • Currently enrolled in other drug trials that preclude investigational treatment with CoV-2 convalescent plasma transfusion

Treatment and study plan

COVID Convalescent Plasma

Biological

One unit of COVID Convalescent Plasma transfused on Day 0

Other names: CCP, COVID-19 Convalescent Plasma

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gailen D. Marshall Jr., MD PhD

Other

Collaborators

  • University of Mississippi Medical Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2020
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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