Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
NCT ID: NCT04393311
Last Updated: 2022-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2022-02-28
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ulinastatin
Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
Placebo
Patients will receive placebo to match ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
Placebo
Placebo to match ulinastatin administered via IV infusion
Interventions
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Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
Placebo
Placebo to match ulinastatin administered via IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Kevin V Grimes, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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56639
Identifier Type: -
Identifier Source: org_study_id
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