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Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

Primary Purpose

Respiratory Infection Virus, Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sivelestat Sodium for Injection
The Placebo
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Infection Virus focused on measuring ARDS, COVID-19, Sivelestat, Randomized Trial

Eligibility Criteria

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

Inclusion Criteria: Age ≥18 years old Confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR) in sputum, nasopharyngeal swabs, or oropharyngeal swabs Diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition criteria Onset of ARDS less than 72 hours before randomization Written informed consent Exclusion Criteria: ARDS potentially caused by extra-pulmonary reasons, including non-pulmonary sepsis, pancreatitis, multiple trauma and massive transfusion, etc. Leukopenia (leukocyte count <4,000/μL/) and/or thrombocytopenia (platelet count <100,000/μL) Significant hepatic dysfunction, defined as elevated AST and ALT ≥ 3 times the normal limits, or total bilirubin ≥ 1.5 mg/dL Severe renal insufficiency with serum creatinine > 3.0 mg/dL History of moderate to severe chronic lung disease requiring home-based oxygen therapy, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), asthma and bronchiectasis, etc. Pre-existing peripheral nerve injury, spinal cord trauma, or neuromuscular disorder that may impair spontaneous ventilation (e.g., high cervical spinal cord injury, Guillain-Barré Syndrome, and myasthenia gravis, etc.) Current diagnosis of pulmonary embolism Coexisting multi-organ failure, affecting more than 3 systems Combined with burn injury Life expectancy less than 6 months (e.g., due to an an end-stage malignant disease) Moribund and expected to die within 48 hours Known allergy to sivelestat or any of the study drug excipients Pregnancy or lactation, or the possibility of conception Current or recent (last 3 months) participation in any other clinical trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    the Sivelestat group

    The Placebo group

    Arm Description

    The patients in this group will receive sivelestat sodium via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days

    The patients in this group will receive the placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days

    Outcomes

    Primary Outcome Measures

    PaO2/FiO2 ratio
    Changes in the PaO2/FiO2 ratio

    Secondary Outcome Measures

    Ventilator-Free days
    The number of Ventilator-Free Days
    In-hospital mortality
    The rate of death during hospitalization
    Length of hospitalization
    The overall length of hospital stay
    Intensive care unit (ICU) length of stay
    The time interval between ICU admission and ICU discharge

    Full Information

    First Posted
    January 16, 2023
    Last Updated
    January 22, 2023
    Sponsor
    Beijing Tiantan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05697016
    Brief Title
    Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19
    Official Title
    Sivelestat for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome Due to COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    January 3, 2024 (Anticipated)
    Study Completion Date
    January 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Tiantan Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    A randomized, double-Blind, placebo-controlled trial aimed to investigate the safety and efficacy of sivelestat on treating adult patients with COVID-19-related acute respiratory distress syndrome (ARDS)
    Detailed Description
    This study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in China from January 1, 2023, to January 31, 2024. During the study period, we intend to enroll a total of 238 eligible patients. These patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or ICU discharge if it occurs before day 7). Both the patients and investigators are blinded to the treatment assignment. Subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. The primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. Also, endpoint assessors are masked to the treatment allocation. Lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for COVID-19-associated ARDS

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Infection Virus, Respiratory Failure
    Keywords
    ARDS, COVID-19, Sivelestat, Randomized Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    238 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the Sivelestat group
    Arm Type
    Experimental
    Arm Description
    The patients in this group will receive sivelestat sodium via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days
    Arm Title
    The Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    The patients in this group will receive the placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Sivelestat Sodium for Injection
    Other Intervention Name(s)
    Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines
    Intervention Description
    Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl]amino-acetate tetrahydrate]
    Intervention Type
    Drug
    Intervention Name(s)
    The Placebo
    Other Intervention Name(s)
    Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines
    Intervention Description
    Excipients used for the sivelestat sodium
    Primary Outcome Measure Information:
    Title
    PaO2/FiO2 ratio
    Description
    Changes in the PaO2/FiO2 ratio
    Time Frame
    From randomization to day 7
    Secondary Outcome Measure Information:
    Title
    Ventilator-Free days
    Description
    The number of Ventilator-Free Days
    Time Frame
    From randomization to day 28
    Title
    In-hospital mortality
    Description
    The rate of death during hospitalization
    Time Frame
    Through study completion, a period of 28 days
    Title
    Length of hospitalization
    Description
    The overall length of hospital stay
    Time Frame
    Through study completion, a period of 28 days
    Title
    Intensive care unit (ICU) length of stay
    Description
    The time interval between ICU admission and ICU discharge
    Time Frame
    Through study completion, a period of 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years old Confirmed SARS-CoV-2 infection as determined by Polymerase Chain Reaction (PCR) in sputum, nasopharyngeal swabs, or oropharyngeal swabs Diagnosis of acute respiratory distress syndrome (ARDS) according to the Berlin Definition criteria Onset of ARDS less than 72 hours before randomization Written informed consent Exclusion Criteria: ARDS potentially caused by extra-pulmonary reasons, including non-pulmonary sepsis, pancreatitis, multiple trauma and massive transfusion, etc. Leukopenia (leukocyte count <4,000/μL/) and/or thrombocytopenia (platelet count <100,000/μL) Significant hepatic dysfunction, defined as elevated AST and ALT ≥ 3 times the normal limits, or total bilirubin ≥ 1.5 mg/dL Severe renal insufficiency with serum creatinine > 3.0 mg/dL History of moderate to severe chronic lung disease requiring home-based oxygen therapy, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), asthma and bronchiectasis, etc. Pre-existing peripheral nerve injury, spinal cord trauma, or neuromuscular disorder that may impair spontaneous ventilation (e.g., high cervical spinal cord injury, Guillain-Barré Syndrome, and myasthenia gravis, etc.) Current diagnosis of pulmonary embolism Coexisting multi-organ failure, affecting more than 3 systems Combined with burn injury Life expectancy less than 6 months (e.g., due to an an end-stage malignant disease) Moribund and expected to die within 48 hours Known allergy to sivelestat or any of the study drug excipients Pregnancy or lactation, or the possibility of conception Current or recent (last 3 months) participation in any other clinical trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jingwei Zhao, M.D.
    Phone
    86-010-59975098
    Email
    126-zjw@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bin Zhu, M.D.
    Phone
    86-010-59975442
    Email
    zbtcm@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guangzhi Shi, M.D.
    Organizational Affiliation
    Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Zhigang Zhao, M.D.
    Organizational Affiliation
    Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

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