Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

Not Applicable

Not yet recruiting

• Conditions: Respiratory Infection Virus; Respiratory Failure
• Interventions: Drug: The Placebo; Drug: Sivelestat Sodium for Injection

• Registration Number: NCT05697016
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-22
• Last Update Submitted: 2023-01-22
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Study Start: 2023-01-31
• Primary Completion: 2024-01-03
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Placebo group	The Placebo	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
the Sivelestat group	Sivelestat Sodium for Injection	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

Primary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio	From randomization to day 7	Changes in the PaO2/FiO2 ratio

Secondary Outcome Measures

Name	Time	Method
Ventilator-Free days	From randomization to day 28	The number of Ventilator-Free Days
In-hospital mortality	Through study completion, a period of 28 days	The rate of death during hospitalization
Length of hospitalization	Through study completion, a period of 28 days	The overall length of hospital stay
Intensive care unit (ICU) length of stay	Through study completion, a period of 28 days	The time interval between ICU admission and ICU discharge