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Widespread vaccine availability
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This is a pilot study designed to demonstrate the feasibility of conducting a larger study of standard plasma therapy in COVID-19 patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Arm | No Intervention | Participants randomized to standard care will not receive an intervention but will participate in other study procedures, which are blood collection and data collection. | |
| Intervention Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thawed plasma | Biological | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rondi Gelbard, MD | University of Alabama at Birmingham | Principal Investigator |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Group 1: Standard care for COVID-19 Group 2: Standard care plus non-convalescent plasma infusion
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Masking will not be used. Participants randomized to standard care will not receive a sham treatment.
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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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |