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.
Drug: Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
Drug: Placebo
Placebo to match ulinastatin administered via IV infusion
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
Stanford University
Stanford, California, United States
Kevin V Grimes, MD, Principal Investigator
Stanford University