Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

NCT ID: NCT05697016

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-01-31

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

Conditions

Respiratory Infection Virus; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

the Sivelestat group

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

Group Type: EXPERIMENTAL

Sivelestat Sodium for Injection

Intervention Type: DRUG

Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-\[2-\[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl\]amino-acetate tetrahydrate\]

The Placebo group

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

Group Type: PLACEBO_COMPARATOR

The Placebo

Intervention Type: DRUG

Excipients used for the sivelestat sodium

Interventions

Sivelestat Sodium for Injection

Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-\[2-\[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl\]amino-acetate tetrahydrate\]

Intervention Type: DRUG

The Placebo

Excipients used for the sivelestat sodium

Intervention Type: DRUG

Other Intervention Names

Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines; Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guangzhi Shi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guangzhi Shi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University

Zhigang Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University

Central Contacts

Jingwei Zhao, M.D.

Role: CONTACT

126-zjw@163.com

86-010-59975098

Bin Zhu, M.D.

Role: CONTACT

zbtcm@163.com

86-010-59975442

Other Identifiers

HX-B-2022083

Identifier Type: -

Identifier Source: org_study_id