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

Phase 2

Withdrawn

• Conditions: COVID-19
• Interventions: Biological: Thawed plasma

• Registration Number: NCT04723589
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Study Start: 2021-04-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-26
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Thawed plasma	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.

Primary Outcome Measures

Name	Time	Method
Number of participants completing plasma infusion for COVID-19	Track patient progress for 30 days post transfusion.	Identification of patient population who are COVID-19-positive and transfused with plasma
Number of participants intubated	Track patient progress for 30 days post transfusion	Participants who are intubated during hospital stay

Secondary Outcome Measures

Name	Time	Method
Soluble Thrombomodulin blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test indicates blood vessel injury
Factor VIII blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test measures a blood clotting protein
National Early Warning Score change	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.
In hospital mortality	Track patient progress for 30 days post transfusion	Number of patients who receive transfusion but do not survive for 30 days
Syndecan-1 blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test indicates blood vessel injury
Intensive care unit-free Days	Track patient progress for 30 days post transfusion	Number of days patient is hospitalized and not in ICU
Angiopoietin 1&2 blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	Angiopoietin, a protein, that plays a role in blood vessel formation
Soluble Tie2 blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	Soluble Tie2 is a protein that mediates the function of angiopoietin
Prothrombin time blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test measures blood coagulation
Fibrinogen blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	Tests for a protein important to clotting
Sequential Organ Failure Assessment (SOFA) score change	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.
Ventilator-free Days	Track patient progress for 30 days post transfusion	Number of in-hospital days that patient is not ventilated
Partial thromboplastin time blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test measures blood coagulation
Von Willebrand Factor Antigen blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	This test measures a blood clotting protein
D-dimer blood test	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
Thromboelastography blood test	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.	Measures blood coagulation