©2024 Stanford Medicine
Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Not Recruiting
Trial ID: NCT04393311
Purpose
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.
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Stanford Investigator(s)
Kevin Grimes
Professor (Teaching) of Chemical and Systems Biology
Eligibility
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
Intervention(s):
drug: Ulinastatin
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305