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Withdrawn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
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring plasma
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
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
NCT ID
NCT04723589
First Posted
November 26, 2020
Last Updated
June 26, 2021
Sponsor
University of Alabama at Birmingham
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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