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Convalescent Plasma to Limit Coronavirus Associated Complications

Primary Purpose

Coronavirus

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Convalescent Plasma
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronavirus focused on measuring 2019 novel Coronavirus, SARS-CoV-2, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be 18 years of age or older
  • Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements.
  • Patient agrees to storage of specimens for future testing.

Exclusion Criteria:

  • Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period
  • Receipt of pooled immunoglobulin in past 30 days
  • Contraindication to transfusion or history of prior reactions to transfusion blood products

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Convalescent Plasma Group

    Arm Description

    Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64.

    Outcomes

    Primary Outcome Measures

    RNA in SARS-CoV-2
    Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
    ICU Admissions
    Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
    Hospital Mortality
    Total number of subject deaths.
    Hospital Length of Stay (LOS)
    The total number of days subjects were admitted to the hospital.

    Secondary Outcome Measures

    Type of respiratory support
    The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
    Duration of respiratory support
    The total number of days subjects required respiratory support.

    Full Information

    First Posted
    March 26, 2020
    Last Updated
    April 6, 2020
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04325672
    Brief Title
    Convalescent Plasma to Limit Coronavirus Associated Complications
    Official Title
    Convalescent Plasma to Limit Coronavirus Associated Complications: An Open Label, Phase 2A Study of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study stopped due to opening Expanded Access Protocol.
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Researchers are trying to assess the treatment potential and safety of anti-SARS-CoV-2 convalescent plasma in patients with acute respiratory symptoms with confirmed COVID-19.
    Detailed Description
    High titer human convalescent plasma will be extracted from apheresis donations from twenty recently-sick and currently-recovered COVID-19 patients. An open-label, phase 2A clinical trial will then be conducted to administer convalescent plasma to twenty individuals with confirmed cases of COVID-19 to investigate the novel application of convalescent plasma in the treatment strategy of SARS-CoV-2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronavirus
    Keywords
    2019 novel Coronavirus, SARS-CoV-2, COVID-19

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Convalescent Plasma Group
    Arm Type
    Experimental
    Arm Description
    Subjects will receive 1-2 units (300-600 mL) of plasma with an anti-SARS-CoV-2 titer of >1:64.
    Intervention Type
    Biological
    Intervention Name(s)
    Convalescent Plasma
    Intervention Description
    Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.
    Primary Outcome Measure Information:
    Title
    RNA in SARS-CoV-2
    Description
    Change in RNA levels of SARS-CoV-2 from nasopharyngeal using RT-PCR (reverse transcriptase polymerase chain reaction) across time.
    Time Frame
    Days 0, 1, 3, 7, 14, 28, 60 and 90 after transfusion
    Title
    ICU Admissions
    Description
    Total number of subjects to be admitted to the ICU after the anti-SARS-CoV-2 convalescent plasma transfusion.
    Time Frame
    90 days after transfusion
    Title
    Hospital Mortality
    Description
    Total number of subject deaths.
    Time Frame
    90 days after transfusion
    Title
    Hospital Length of Stay (LOS)
    Description
    The total number of days subjects were admitted to the hospital.
    Time Frame
    90 days after transfusion
    Secondary Outcome Measure Information:
    Title
    Type of respiratory support
    Description
    The type of supplemental oxygen support (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, intubation and invasive mechanical ventilation, rescue ventilation) of the anti-SARS-CoV-2 convalescent plasma group across time.
    Time Frame
    90 days after transfusion or until hospital discharge (whichever comes first)
    Title
    Duration of respiratory support
    Description
    The total number of days subjects required respiratory support.
    Time Frame
    90 days after transfusion or until hospital discharge (whichever comes first)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be 18 years of age or older Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing. Patient is willing and able to provide written informed consent and comply with all protocol requirements. Patient agrees to storage of specimens for future testing. Exclusion Criteria: Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period Receipt of pooled immunoglobulin in past 30 days Contraindication to transfusion or history of prior reactions to transfusion blood products
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Joyner, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

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