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Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

Stanford University logo

Stanford University

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

COVID-19

Treatments

Drug: Placebo
Drug: Ulinastatin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

Ulinastatin
Experimental group
Description:
Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
Treatment:
Drug: Ulinastatin
Placebo
Placebo Comparator group
Description:
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).
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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