Clinical trial NCT04723589: Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
Official title: Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: plasma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants completing plasma infusion for COVID-19
timeFrame: Track patient progress for 30 days post transfusion.
measure: Number of participants intubated
timeFrame: Track patient progress for 30 days post transfusion
Secondary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score change
timeFrame: Track patient progress for 30 days post transfusion
measure: National Early Warning Score change
timeFrame: Track patient progress for 30 days post transfusion
measure: Ventilator-free Days
timeFrame: Track patient progress for 30 days post transfusion
measure: Intensive care unit-free Days
timeFrame: Track patient progress for 30 days post transfusion
measure: In hospital mortality
timeFrame: Track patient progress for 30 days post transfusion
measure: Angiopoietin 1&2 blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Soluble Tie2 blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Soluble Thrombomodulin blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Syndecan-1 blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Prothrombin time blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Partial thromboplastin time blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: D-dimer blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Fibrinogen blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Thromboelastography blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Von Willebrand Factor Antigen blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
measure: Factor VIII blood test
timeFrame: 0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Rondi Gelbard, MD
role: PRINCIPAL_INVESTIGATOR
References: