Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

September 1, 2025

Conditions
Acute Respiratory Distress Syndrome
Interventions
DRUG

Sivelestat sodium

Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)

DRUG

Dexamethasone

Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)

DRUG

Sivelestat sodium placebo

Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)

DRUG

Dexamethasone placebo

Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)

Trial Locations (4)

100730

RECRUITING

Peking Union Medical College Hospital, Beijing

Unknown

NOT_YET_RECRUITING

Luoyang Central Hospital, Luoyang

RECRUITING

Yanan University Affiliated Hospital, Yan’an

NOT_YET_RECRUITING

The Third Hospital of Mianyang, Mianyang

All Listed Sponsors
collaborator

Peking University

OTHER

collaborator

Shanghai Huilun Pharmaceutical Co., Ltd.

INDUSTRY

lead

Peking Union Medical College Hospital

OTHER