Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

Stanford University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

COVID-19

Interventions

UlinastatinDRUG

Ulinastatin administered via IV infusion (200,000/infusion)

PlaceboDRUG

Placebo to match ulinastatin administered via IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Stanford, California, United States

Outcomes

Primary Outcomes

Time to recovery

Time to recovery, defined as attaining a score of 6, 7, or 8 on the COVID-19 disease severity scale, an 8 point ordinal scale used in the NIH Adaptive COVID-19 Treatment Trial (ACTT; NCT04280705). 1. = Death; 2. = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; 4. = Hospitalized and requiring supplemental oxygen; 5. = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); 6. = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; 7. = Not hospitalized, limitation on activities and/or requiring home oxygen; 8. = Not hospitalized, no limitation on activities

Time frame: Up to 29 days

Secondary Outcomes

COVID-19 disease severity scale score on Day 8

COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

Time frame: Day 8

COVID-19 disease severity scale score on Day 15

COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

Time frame: Day 15

COVID-19 disease severity scale score on Day 22

COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

Time frame: Day 22

COVID-19 disease severity scale score on Day 29

COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

Time frame: Day 29

Incidence of mortality at Day 29

Time frame: 29 days

Data from ClinicalTrials.gov

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