COVID-19
Conditions
Brief summary
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.
Interventions
DRUGUlinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
DRUGPlacebo
Placebo to match ulinastatin administered via IV infusion
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide written informed consent * Signs and symptoms suggestive of COVID-19 infection * Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection ≤7 days before randomization * Currently hospitalized or in an emergency department with planned hospitalization * Peripheral capillary oxygen saturation (SpO2) \<93% on room air at Screening
Exclusion criteria
* Simultaneous participation in any other clinical study incompatible with this one * Treatment with an antibody immunotherapy within 4 weeks of Screening * Requirement for mechanical ventilation or ECMO at Screening * Hypotension at Screening * Severe liver injury defined as AST or ALT ≥5x the upper limit of normal * Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min * Pregnancy or breastfeeding * \> 120 hours between admission and signing consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery | Up to 29 days | 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). 1. = Death; 2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; 4. = Hospitalized and requiring supplemental oxygen; 5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); 6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; 7. = Not hospitalized, limitation on activities and/or requiring home oxygen; 8. = Not hospitalized, no limitation on activities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mortality at Day 29 | 29 days | — |
| COVID-19 disease severity scale score on Day 8 | Day 8 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| COVID-19 disease severity scale score on Day 15 | Day 15 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| COVID-19 disease severity scale score on Day 22 | Day 22 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| 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 | — |
| COVID-19 disease severity scale score on Day 29 | Day 29 | COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state). |
| Duration of mechanical ventilation | Up to 29 days | For patients requiring mechanical ventilation. |
| Duration of ECMO | Up to 29 days | For patients requiring mechanical ECMO. |
| Duration of noninvasive ventilation | Up to 29 days | For patients requiring non-invasive ventilation |
| Duration of ICU stay | Up to 29 days | For patients admitted to ICU |
| Duration of hospital stay | Up to 29 days | — |
| Change in oxygen saturation | Between screening and 24 hours after last dose (up to 6 days) | — |
| 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 | — |
Countries
United States
Outcome results
None listed