Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ulinastatin 		Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
  • Drug: Ulinastatin
    Ulinastatin administered via IV infusion (200,000/infusion)
Placebo Comparator
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).
  • Drug: Placebo
    Placebo to match ulinastatin administered via IV infusion

Recruiting Locations

More Details

NCT ID
NCT04393311
Status
Withdrawn
Sponsor
Stanford University