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Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC) (RELIC)

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thawed plasma
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring plasma

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older
  • COVID-19 positive by PCR or assay within 72 hours or less
  • Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening

Exclusion Criteria:

  • mechanically ventilated
  • pregnant
  • prisoners
  • receiving resuscitation with blood products for hemorrhagic shock
  • receiving an investigational therapy for COVID-19
  • diagnosed with severe comorbidities
  • not expected to survive more than 24 hours

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Arm

    Intervention Arm

    Arm Description

    Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection.

    Participants randomized to the intervention arm will receive standard care plus an infusion of thawed plasma, starting rate 30 ml/hour for 24 hours, increased to 50 ml/hour if deemed to be hypovolemic (low fluid volume). Only non-convalescent (COVID-antibody-free) plasma will be used.

    Outcomes

    Primary Outcome Measures

    Number of participants completing plasma infusion for COVID-19
    Identification of patient population who are COVID-19-positive and transfused with plasma
    Number of participants intubated
    Participants who are intubated during hospital stay

    Secondary Outcome Measures

    Sequential Organ Failure Assessment (SOFA) score change
    SOFA is used as a clinical indicator of morbidity severity. The scale is 0-24, with 0 being normal.
    National Early Warning Score change
    This score is used as a clinical indicator of patient deterioration. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk.
    Ventilator-free Days
    Number of in-hospital days that patient is not ventilated
    Intensive care unit-free Days
    Number of days patient is hospitalized and not in ICU
    In hospital mortality
    Number of patients who receive transfusion but do not survive for 30 days
    Angiopoietin 1&2 blood test
    Angiopoietin, a protein, that plays a role in blood vessel formation
    Soluble Tie2 blood test
    Soluble Tie2 is a protein that mediates the function of angiopoietin
    Soluble Thrombomodulin blood test
    This test indicates blood vessel injury
    Syndecan-1 blood test
    This test indicates blood vessel injury
    Prothrombin time blood test
    This test measures blood coagulation
    Partial thromboplastin time blood test
    This test measures blood coagulation
    D-dimer blood test
    This test measures for D-dimer concentration, indicating that the blood has been breaking down blood clots
    Fibrinogen blood test
    Tests for a protein important to clotting
    Thromboelastography blood test
    Measures blood coagulation
    Von Willebrand Factor Antigen blood test
    This test measures a blood clotting protein
    Factor VIII blood test
    This test measures a blood clotting protein

    Full Information

    First Posted
    November 26, 2020
    Last Updated
    June 26, 2021
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04723589
    Brief Title
    Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
    Acronym
    RELIC
    Official Title
    Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Widespread vaccine availability
    Study Start Date
    April 30, 2021 (Actual)
    Primary Completion Date
    April 30, 2021 (Actual)
    Study Completion Date
    April 30, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
    Detailed Description
    This is a randomized trial in hospitalized COVID-19-positive patients. This trial compares standard care to standard care plus an infusion of non-convalescent thawed plasma. Blood will be collected from all participants at eight timepoints, and clinical data will be collected for 30 days or until discharge/death.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    plasma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
    Masking
    None (Open Label)
    Masking Description
    Masking will not be used. Participants randomized to standard care will not receive a sham treatment.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Arm
    Arm Type
    No Intervention
    Arm Description
    Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection.
    Arm Title
    Intervention Arm
    Arm Type
    Experimental
    Arm Description
    Participants randomized to the intervention arm will receive standard care plus an infusion of thawed plasma, starting rate 30 ml/hour for 24 hours, increased to 50 ml/hour if deemed to be hypovolemic (low fluid volume). Only non-convalescent (COVID-antibody-free) plasma will be used.
    Intervention Type
    Biological
    Intervention Name(s)
    Thawed plasma
    Intervention Description
    Plasma not labeled "convalescent plasma" is presumed to be free of COVID antibodies, but is not tested for antibodies. To ensure that we are using antibody-free plasma, we will test each unit of plasma with a quick COVID test before it is utilized in this study.
    Primary Outcome Measure Information:
    Title
    Number of participants completing plasma infusion for COVID-19
    Description
    Identification of patient population who are COVID-19-positive and transfused with plasma
    Time Frame
    Track patient progress for 30 days post transfusion.
    Title
    Number of participants intubated
    Description
    Participants who are intubated during hospital stay
    Time Frame
    Track patient progress for 30 days post transfusion
    Secondary Outcome Measure Information:
    Title
    Sequential Organ Failure Assessment (SOFA) score change
    Description
    SOFA is used as a clinical indicator of morbidity severity. The scale is 0-24, with 0 being normal.
    Time Frame
    Track patient progress for 30 days post transfusion
    Title
    National Early Warning Score change
    Description
    This score is used as a clinical indicator of patient deterioration. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk.
    Time Frame
    Track patient progress for 30 days post transfusion
    Title
    Ventilator-free Days
    Description
    Number of in-hospital days that patient is not ventilated
    Time Frame
    Track patient progress for 30 days post transfusion
    Title
    Intensive care unit-free Days
    Description
    Number of days patient is hospitalized and not in ICU
    Time Frame
    Track patient progress for 30 days post transfusion
    Title
    In hospital mortality
    Description
    Number of patients who receive transfusion but do not survive for 30 days
    Time Frame
    Track patient progress for 30 days post transfusion
    Title
    Angiopoietin 1&2 blood test
    Description
    Angiopoietin, a protein, that plays a role in blood vessel formation
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Soluble Tie2 blood test
    Description
    Soluble Tie2 is a protein that mediates the function of angiopoietin
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Soluble Thrombomodulin blood test
    Description
    This test indicates blood vessel injury
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Syndecan-1 blood test
    Description
    This test indicates blood vessel injury
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Prothrombin time blood test
    Description
    This test measures blood coagulation
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Partial thromboplastin time blood test
    Description
    This test measures blood coagulation
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    D-dimer blood test
    Description
    This test measures for D-dimer concentration, indicating that the blood has been breaking down blood clots
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Fibrinogen blood test
    Description
    Tests for a protein important to clotting
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Thromboelastography blood test
    Description
    Measures blood coagulation
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Von Willebrand Factor Antigen blood test
    Description
    This test measures a blood clotting protein
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
    Title
    Factor VIII blood test
    Description
    This test measures a blood clotting protein
    Time Frame
    0, 12, 24, 48, 72 hours. Day 7, 14 and 30.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older COVID-19 positive by PCR or assay within 72 hours or less Oxygen saturation of ≤94% on room air or requiring supplemental oxygen at screening Exclusion Criteria: mechanically ventilated pregnant prisoners receiving resuscitation with blood products for hemorrhagic shock receiving an investigational therapy for COVID-19 diagnosed with severe comorbidities not expected to survive more than 24 hours
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rondi Gelbard, MD
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)

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