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

COVID-19 Clinical Trial

— RELIC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04723589
• Other study ID #: IRB-300005853
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 30, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Number of participants intubated	Participants who are intubated during hospital stay	Track patient progress for 30 days post transfusion
Secondary	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
Secondary	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
Secondary	Ventilator-free Days	Number of in-hospital days that patient is not ventilated	Track patient progress for 30 days post transfusion
Secondary	Intensive care unit-free Days	Number of days patient is hospitalized and not in ICU	Track patient progress for 30 days post transfusion
Secondary	In hospital mortality	Number of patients who receive transfusion but do not survive for 30 days	Track patient progress for 30 days post transfusion
Secondary	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.
Secondary	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.
Secondary	Soluble Thrombomodulin blood test	This test indicates blood vessel injury	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Syndecan-1 blood test	This test indicates blood vessel injury	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Prothrombin time blood test	This test measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Partial thromboplastin time blood test	This test measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	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.
Secondary	Fibrinogen blood test	Tests for a protein important to clotting	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Thromboelastography blood test	Measures blood coagulation	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Von Willebrand Factor Antigen blood test	This test measures a blood clotting protein	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.
Secondary	Factor VIII blood test	This test measures a blood clotting protein	0, 12, 24, 48, 72 hours. Day 7, 14 and 30.