Trial Search Results

Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Ulinastatin
  • Drug: Placebo

Phase:

Phase 1/Phase 2

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

   - Abnormal liver function

   - Abnormal kidney function

   - Pregnancy or breastfeeding

   - > 120 hours between admission and signing consent

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting