Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
NCT04393311 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2022-03-03
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.
Conditions
Interventions
- DRUG
-
Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
- DRUG
-
Placebo to match ulinastatin administered via IV infusion
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Kevin V Grimes, MD · Stanford University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-28
- Primary Completion
- 2022-08-31
- Completion
- 2022-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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