Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

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Status and phase: Withdrawn; Phase 2; Phase 1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

NCT04393311

56639

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

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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