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Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19

NCT05697016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-01-25

No results posted yet for this study

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

Interventions

DRUG

Sivelestat Sodium for Injection

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

DRUG

The Placebo

Excipients used for the sivelestat sodium

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Guangzhi Shi, M.D. · Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University

  • Zhigang Zhao, M.D. · Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-03
Completion
2024-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697016 on ClinicalTrials.gov