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

This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: Biological: Thawed plasma

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 Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Track patient progress for 30 days post transfusion
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.	Track patient progress for 30 days post transfusion
Ventilator-free Days	Number of in-hospital days that patient is not ventilated	Track patient progress for 30 days post transfusion
Intensive care unit-free Days	Number of days patient is hospitalized and not in ICU	Track patient progress for 30 days post transfusion
In hospital mortality	Number of patients who receive transfusion but do not survive for 30 days	Track patient progress for 30 days post transfusion
Angiopoietin 1&2 blood test	Angiopoietin, a protein, that plays a role in blood vessel formation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Tie2 blood test	Soluble Tie2 is a protein that mediates the function of angiopoietin	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Soluble Thrombomodulin blood test	This test indicates blood vessel injury	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Syndecan-1 blood test	This test indicates blood vessel injury	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Prothrombin time blood test	This test measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Partial thromboplastin time blood test	This test measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
D-dimer blood test	This test measures for D-dimer concentration, indicating that the blood has been breaking down blood clots	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Fibrinogen blood test	Tests for a protein important to clotting	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Thromboelastography blood test	Measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Von Willebrand Factor Antigen blood test	This test measures a blood clotting protein	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Factor VIII blood test	This test measures a blood clotting protein	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Rondi Gelbard, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB-300005853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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