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Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ulinastatin
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ulinastatin

Placebo

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

COVID-19 disease severity scale score on Day 8
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
COVID-19 disease severity scale score on Day 15
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
COVID-19 disease severity scale score on Day 22
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
COVID-19 disease severity scale score on Day 29
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Incidence of mortality at Day 29
Incidence of in-hospital mortality
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29
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
Duration of mechanical ventilation
For patients requiring mechanical ventilation.
Duration of ECMO
For patients requiring mechanical ECMO.
Duration of noninvasive ventilation
For patients requiring non-invasive ventilation
Duration of ICU stay
For patients admitted to ICU
Duration of hospital stay
Change in oxygen saturation

Full Information

First Posted
May 15, 2020
Last Updated
February 15, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04393311
Brief Title
Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Discontinuation of drug candidates
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ulinastatin
Arm Type
Experimental
Arm Description
Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Ulinastatin
Intervention Description
Ulinastatin administered via IV infusion (200,000/infusion)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match ulinastatin administered via IV infusion
Primary Outcome Measure Information:
Title
Time to recovery
Description
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
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
COVID-19 disease severity scale score on Day 8
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 8
Title
COVID-19 disease severity scale score on Day 15
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 15
Title
COVID-19 disease severity scale score on Day 22
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 22
Title
COVID-19 disease severity scale score on Day 29
Description
COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).
Time Frame
Day 29
Title
Incidence of mortality at Day 29
Time Frame
29 days
Title
Incidence of in-hospital mortality
Time Frame
Up to 29 days
Title
Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose
Time Frame
Up to 29 days
Title
Number of patients with resolution of symptoms defined as score of 8 on the 8-point ordinal scale at Day 29
Time Frame
Day 29
Title
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
Time Frame
Day 29
Title
Duration of mechanical ventilation
Description
For patients requiring mechanical ventilation.
Time Frame
Up to 29 days
Title
Duration of ECMO
Description
For patients requiring mechanical ECMO.
Time Frame
Up to 29 days
Title
Duration of noninvasive ventilation
Description
For patients requiring non-invasive ventilation
Time Frame
Up to 29 days
Title
Duration of ICU stay
Description
For patients admitted to ICU
Time Frame
Up to 29 days
Title
Duration of hospital stay
Time Frame
Up to 29 days
Title
Change in oxygen saturation
Time Frame
Between screening and 24 hours after last dose (up to 6 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin V Grimes, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.

Learn more about this trial

Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

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