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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723589
Recruitment Status : Withdrawn (Widespread vaccine availability)
First Posted : January 25, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Rondi Gelbard, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Thawed plasma Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
Actual Study Start Date : April 30, 2021
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard Arm
Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection.
Experimental: Intervention Arm
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.
 Biological: Thawed plasma
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants completing plasma infusion for COVID-19 [ Time Frame: Track patient progress for 30 days post transfusion. ]
    Identification of patient population who are COVID-19-positive and transfused with plasma

  2. Number of participants intubated [ Time Frame: Track patient progress for 30 days post transfusion ]
    Participants who are intubated during hospital stay


Secondary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) score change [ Time Frame: Track patient progress for 30 days post transfusion ]
    SOFA is used as a clinical indicator of morbidity severity. The scale is 0-24, with 0 being normal.

  2. National Early Warning Score change [ Time Frame: Track patient progress for 30 days post transfusion ]
    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.

  3. Ventilator-free Days [ Time Frame: Track patient progress for 30 days post transfusion ]
    Number of in-hospital days that patient is not ventilated

  4. Intensive care unit-free Days [ Time Frame: Track patient progress for 30 days post transfusion ]
    Number of days patient is hospitalized and not in ICU

  5. In hospital mortality [ Time Frame: Track patient progress for 30 days post transfusion ]
    Number of patients who receive transfusion but do not survive for 30 days

  6. Angiopoietin 1&2 blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    Angiopoietin, a protein, that plays a role in blood vessel formation

  7. Soluble Tie2 blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    Soluble Tie2 is a protein that mediates the function of angiopoietin

  8. Soluble Thrombomodulin blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test indicates blood vessel injury

  9. Syndecan-1 blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test indicates blood vessel injury

  10. Prothrombin time blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test measures blood coagulation

  11. Partial thromboplastin time blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test measures blood coagulation

  12. D-dimer blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test measures for D-dimer concentration, indicating that the blood has been breaking down blood clots

  13. Fibrinogen blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    Tests for a protein important to clotting

  14. Thromboelastography blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    Measures blood coagulation

  15. Von Willebrand Factor Antigen blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test measures a blood clotting protein

  16. Factor VIII blood test [ Time Frame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. ]
    This test measures a blood clotting protein


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723589


Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Rondi Gelbard, MD University of Alabama at Birmingham
More Information
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Responsible Party: Rondi Gelbard, Associate Professor, Department of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04723589    
Other Study ID Numbers: IRB-300005853
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Rondi Gelbard, University of Alabama at Birmingham:
plasma
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases