Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

NCT04393311 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 56639
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 29 days

Secondary Outcomes (15)

• COVID-19 disease severity scale score on Day 8

  Day 8

• COVID-19 disease severity scale score on Day 15

  Day 15

• COVID-19 disease severity scale score on Day 22

  Day 22

• COVID-19 disease severity scale score on Day 29

  Day 29

• Incidence of mortality at Day 29

  29 days

Study Arms (2)

Ulinastatin

EXPERIMENTAL

Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).

Drug: Ulinastatin

Placebo

PLACEBO COMPARATOR

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

Interventions

Ulinastatin DRUG

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

Ulinastatin

Placebo DRUG

Placebo to match ulinastatin administered via IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

urinastatin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kevin V Grimes, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)