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Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients

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ClinicalTrials.gov Identifier: NCT04393311
Recruitment Status : Not yet recruiting
First Posted : May 19, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ulinastatin Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ulinastatin
Patients will receive ulinastatin via IV infusion every 8 hours for up to 5 days or until hospital discharge (whichever is earlier).
 Drug: Ulinastatin
Ulinastatin administered via IV infusion (200,000/infusion)
Placebo Comparator: Placebo
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
Placebo to match ulinastatin administered via IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Time to recovery [ Time Frame: Up to 29 days ]

    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


Secondary Outcome Measures :
  1. COVID-19 disease severity scale score on Day 8 [ Time Frame: Day 8 ]
    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

  2. COVID-19 disease severity scale score on Day 15 [ Time Frame: Day 15 ]
    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

  3. COVID-19 disease severity scale score on Day 22 [ Time Frame: Day 22 ]
    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

  4. COVID-19 disease severity scale score on Day 29 [ Time Frame: Day 29 ]
    COVID-19 disease severity scale (range; 1-8, higher scores correspond to better health state).

  5. Incidence of mortality at Day 29 [ Time Frame: 29 days ]
  6. Incidence of in-hospital mortality [ Time Frame: Up to 29 days ]
  7. Number of days alive and not on mechanical ventilator or ECMO in the 28 days following first dose [ Time Frame: Up to 29 days ]
  8. 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 ]
  9. 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 ]
  10. Duration of mechanical ventilation [ Time Frame: Up to 29 days ]
    For patients requiring mechanical ventilation.

  11. Duration of ECMO [ Time Frame: Up to 29 days ]
    For patients requiring mechanical ECMO.

  12. Duration of noninvasive ventilation [ Time Frame: Up to 29 days ]
    For patients requiring non-invasive ventilation

  13. Duration of ICU stay [ Time Frame: Up to 29 days ]
    For patients admitted to ICU

  14. Duration of hospital stay [ Time Frame: Up to 29 days ]
  15. Change in oxygen saturation [ Time Frame: Between screening and 24 hours after last dose (up to 6 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393311


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kevin V Grimes, MD Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04393311    
Other Study ID Numbers: 56639
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action