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Discontinuation of drug candidates
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The primary objective of this study is to evaluate the safety and efficacy of intravenous (IV) infusion of ulinastatin compared to placebo with respect to time to recovery, disease severity, need for ventilator support, and mortality in patients with COVID 19.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulinastatin | Experimental | Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier). |
|
| Placebo | Placebo Comparator | Patients will receive placebo to match ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulinastatin | Drug | Ulinastatin administered via IV infusion (200,000/infusion) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery | Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705).
| Up to 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 disease severity scale score on Day 8 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). | Day 8 |
| COVID-19 disease severity scale score on Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin V Grimes, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
No plan to share data.
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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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| ID | Term |
|---|---|
| C028665 | urinastatin |
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| Placebo |
| Drug |
Placebo to match ulinastatin administered via IV infusion |
|
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
| Day 15 |
| COVID-19 disease severity scale score on Day 22 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). | Day 22 |
| COVID-19 disease severity scale score on Day 29 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). | Day 29 |
| Incidence of mortality at Day 29 | 29 days |
| Incidence of in-hospital mortality | Up to 29 days |
| Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose | Up to 29 days |
| Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29 | Day 29 |
| Number of patients alive and free of respiratory failure defined as score of 4, 5, 6, 7, or 8 on the 8-point ordinal scale at Day 29 | Day 29 |
| Duration of mechanical ventilation | For patients requiring mechanical ventilation. | Up to 29 days |
| Duration of ECMO | For patients requiring mechanical ECMO. | Up to 29 days |
| Duration of noninvasive ventilation | For patients requiring non-invasive ventilation | Up to 29 days |
| Duration of ICU stay | For patients admitted to ICU | Up to 29 days |
| Duration of hospital stay | Up to 29 days |
| Change in oxygen saturation | Between screening and 24 hours after last dose (up to 6 days) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |