Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697016
• Other study ID #: HX-B-2022083
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2023
• Source: Beijing Tiantan Hospital
• Contact: Jingwei Zhao, M.D.
• Phone: 86-010-59975098
• Email: 126-zjw[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 238
• Est. completion date: January 31, 2024
• Est. primary completion date: January 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

Drug:
• Sivelestat Sodium for Injection
Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl]amino-acetate tetrahydrate]
• The Placebo
Excipients used for the sivelestat sodium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PaO2/FiO2 ratio	Changes in the PaO2/FiO2 ratio	From randomization to day 7
Secondary	Ventilator-Free days	The number of Ventilator-Free Days	From randomization to day 28
Secondary	In-hospital mortality	The rate of death during hospitalization	Through study completion, a period of 28 days
Secondary	Length of hospitalization	The overall length of hospital stay	Through study completion, a period of 28 days
Secondary	Intensive care unit (ICU) length of stay	The time interval between ICU admission and ICU discharge	Through study completion, a period of 28 days