COVID-19 Clinical Trial
— RELICOfficial title:
Restoration of Endothelial Integrity in Patients With COVID-19 (RELIC)
Verified date | June 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
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. |
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