Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

NCT05697016 | Unknown DMC

• 1 other identifier: HX-B-2022083
• Study Type: interventional
• Target: 238
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Respiratory Infection Virus; Respiratory Failure

Keywords

ARDS; COVID-19; Sivelestat; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• PaO2/FiO2 ratio

  Changes in the PaO2/FiO2 ratio

  From randomization to day 7

Secondary Outcomes (4)

• Ventilator-Free days

  From randomization to day 28

• In-hospital mortality

  Through study completion, a period of 28 days

• Length of hospitalization

  Through study completion, a period of 28 days

• Intensive care unit (ICU) length of stay

  Through study completion, a period of 28 days

Study Arms (2)

the Sivelestat group

EXPERIMENTAL

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

Drug: Sivelestat Sodium for Injection

The Placebo group

PLACEBO COMPARATOR

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

Drug: The Placebo

Interventions

Sivelestat Sodium for Injection DRUG

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

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

the Sivelestat group

The Placebo DRUG

Excipients used for the sivelestat sodium

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

The Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Respiratory Insufficiency; COVID-19

Interventions

Injections

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Guangzhi Shi, M.D.

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

  PRINCIPAL INVESTIGATOR

• Zhigang Zhao, M.D.

  Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingwei Zhao, M.D.

CONTACT

86-010-59975098; 126-zjw@163.com

Bin Zhu, M.D.

CONTACT

86-010-59975442; zbtcm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 25, 2023
• Study Start: January 31, 2023
• Primary Completion: January 3, 2024
• Study Completion: January 31, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share