Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

COVID-19 Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04393311
• Other study ID #: 56639
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: February 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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
• 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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
• Placebo
Placebo to match ulinastatin administered via IV infusion

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).; = Death; = Hospitalized and on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); = Hospitalized and on non-invasive ventilation or high-flow oxygen devices; = Hospitalized and requiring supplemental oxygen; = Hospitalized and not requiring supplemental oxygen but requiring ongoing medical care (COVID-19-related or otherwise); = Hospitalized and not requiring supplemental oxygen and no longer requiring ongoing medical care; = Not hospitalized, limitation on activities and/or requiring home oxygen; = Not hospitalized, no limitation on activities	Up to 29 days
Secondary	COVID-19 disease severity scale score on Day 8	COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).	Day 8
Secondary	COVID-19 disease severity scale score on Day 15	COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).	Day 15
Secondary	COVID-19 disease severity scale score on Day 22	COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).	Day 22
Secondary	COVID-19 disease severity scale score on Day 29	COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).	Day 29
Secondary	Incidence of mortality at Day 29		29 days
Secondary	Incidence of in-hospital mortality		Up to 29 days
Secondary	Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose		Up to 29 days
Secondary	Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29		Day 29
Secondary	Number of patients alive and free of respiratory failure defined as score of 4, 5, 6, 7, or 8 on the 8-point ordinal scale at Day 29		Day 29
Secondary	Duration of mechanical ventilation	For patients requiring mechanical ventilation.	Up to 29 days
Secondary	Duration of ECMO	For patients requiring mechanical ECMO.	Up to 29 days
Secondary	Duration of noninvasive ventilation	For patients requiring non-invasive ventilation	Up to 29 days
Secondary	Duration of ICU stay	For patients admitted to ICU	Up to 29 days
Secondary	Duration of hospital stay		Up to 29 days
Secondary	Change in oxygen saturation		Between screening and 24 hours after last dose (up to 6 days)