COVID-19
Conditions
Keywords
plasma
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.
Interventions
BIOLOGICALThawed 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking will not be used. Participants randomized to standard care will not receive a sham treatment.
Intervention model description
Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Ventilator-free Days | Track patient progress for 30 days post transfusion | Number of in-hospital days that patient is not ventilated |
| Intensive care unit-free Days | Track patient progress for 30 days post transfusion | Number of days patient is hospitalized and not in ICU |
| In hospital mortality | Track patient progress for 30 days post transfusion | Number of patients who receive transfusion but do not survive for 30 days |
| 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 |
| 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 |
| Prothrombin time blood test | 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. | This test measures blood coagulation |
| Partial thromboplastin time blood test | 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. | This test measures blood coagulation |
| 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 |
| Fibrinogen blood test | 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. | Tests for a protein important to clotting |
| Thromboelastography blood test | 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. | 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 |
| Syndecan-1 blood test | 0, 12, 24, 48, 72 hours. Day 7, 14 and 30. | This test indicates blood vessel injury |
| 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. |
Outcome results
None listed