Status:
WITHDRAWN
Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Lead Sponsor:
Stanford University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04393311
Start Date
February 1 2022
End Date
August 1 2022
Last Update
March 3 2022
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305