Acute Respiratory Distress SyndromeSTARNCT06387823
Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
A study testing Sivelestat sodium and Dexamethasone in people with Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital at 4 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are: Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Sivelestat sodium and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 15 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ARDS
- Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS
- ARDS onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record)
- Patient volunteers to participate in the study and signs an informed consent form
Who cannot join
- Pregnancy or breastfeeding
- brain death
- Advanced cancer or other terminal disease
- History of allergy to Sivelestat Sodium and Dexamethasone
- Severe chronic obstructive pulmonary disease
- History of severe cardiovascular disease, such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled cardiac arrhythmia, uncontrolled hypertension, or history of heart or cerebral infarction within the past six months
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- Organ transplant or allogeneic stem cell transplant recipients
- Fatal active fungal infections
- neuromuscular disease that affects voluntary breathing
- Genetic or acquired severe immunodeficiencies such as human immunodeficiency virus (HIV) infection, chronic granulomatous disease, severe combined immunodeficiencies
- Patients and/or legal representatives who sign a Do Not Resuscitate (DNR) advance directive, or who abandon treatment
- Participating in other clinical trials
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Run Dong, MD, +8613718704355, dongrun5858@foxmail.com
- Not yet recruiting
Luoyang Central Hospital
Luoyang, Henan
Chunyan Li
- Not yet recruiting
The Third Hospital of Mianyang
Mianyang, Sichuan
Qionglan Dong
- Recruiting
Yanan University Affiliated Hospital
Yan’an, Shaanxi
Zhiyan Hui
About this study
Official title: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study
The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:
- Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
- Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Sivelestat sodium, Dexamethasone, Sivelestat sodium placebo, Dexamethasone placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodiumDrug
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
DexamethasoneDrug
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sivelestat sodium placeboDrug
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placeboDrug
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat sodium | Active comparator | Sivelestat sodium and dexamethasone placebo Receives: Drug: Sivelestat sodium; Drug: Dexamethasone placebo |
| Dexamethasone | Active comparator | Dexamethasone and Sivelestat sodium placebo Receives: Drug: Dexamethasone; Drug: Sivelestat sodium placebo |
| Placebo | Placebo comparator | Sivelestat sodium placebo and dexamethasone placebo Receives: Drug: Sivelestat sodium placebo; Drug: Dexamethasone placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day ventilator-free days
ventilator-free days within 28 days
Measured: 28 days after randomization
Informed consent rate
The rate of informed consent
Measured: 90 days after randomization
Recruitment rate
The rate of recruitment
Measured: 90 days after randomization
Recruitment compliance rate
The rate of recruitment compliance
Measured: 90-day after randomization
Protocol adherence rate
The rate of protocol adherence
Measured: 90 days after randomization
Completion of follow-up visits
The rate of completion of follow-up visits
Measured: 90 days after randomization
Secondary outcomes (15)
28-day mortality
28-day mortality
Measured: 28 days after randomization
90-day mortality
90-day mortality
Measured: 90 days after randomization
28-day length of stay
The time interval between randomization and transfer out of ICU. Recorded as 28 days for those who were not transferred out of the ICU 28 days after randomization or those who died during ICU stay
Measured: 28 days after randomization
28-day organ support free day
Days without intensive care-based respiratory or cardiovascular organ support within 28 days of randomization.
Measured: 28 days after randomization
Sequential organ failure assessment (SOFA)
Sequential organ failure assessment (SOFA) score evaluation within 14 days. The minimum value is 0 and maximum value is 24, and higher scores mean a worse outcome.
Measured: 14 days after randomization
Murray's acute lung injury score
Murray's acute lung injury score within 14 days after randomization. The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.
Measured: 14 days after randomization
C-reactive protein (CRP)
C-reactive protein (CRP)
Measured: 14 days after randomization
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Measured: 14 days after randomization
Interleukin-8 (IL-8)
Interleukin-8 (IL-8)
Measured: 14 days after randomization
Procalcitonin (PCT)
Procalcitonin (PCT)
Measured: 14 days after randomization
Neutrophil-to-lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte Ratio (NLR)
Measured: 14 days after randomization
Neutrophil elastase
Neutrophil elastase level of blood and alveolar fluid
Measured: 14 days after randomization
New-onset infection rate
Rate of new-onset infection
Measured: 28 days after randomization
Re-intubation rate
Rate of unplanned re-intubation
Measured: 28 days after randomization
Adverse event
Pneumatic trauma (pneumothorax, mediastinal emphysema, subcutaneous emphysema, or imaging findings), infection, sepsis, respiratory acidosis, severe acidosis (pH < 7.10), refractory hypoxemia (PaO2 < 55 mmHg), severe hypotension (mean arterial pressure < 65 mmHg), new-onset arrhythmia (new-onset atrial fibrillation or supraventricular tachycardia), cardiac arrest, and all serious adverse events
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 Apr 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University, Shanghai Huilun Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bin Du, MD, Study chair, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387823
- Sponsor's protocol ID
- K5321
- Acronym
- STAR
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon proper requirement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06387823
- Acronym / sponsor ID
- STAR / K5321
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University, Shanghai Huilun Pharmaceutical Co., Ltd.
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:
- Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
- Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sivelestat sodium | Active comparator | Drug: Sivelestat sodium, Drug: Dexamethasone placeboSivelestat sodium and dexamethasone placebo |
| Dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Sivelestat sodium placeboDexamethasone and Sivelestat sodium placebo |
| Placebo | Placebo comparator | Drug: Sivelestat sodium placebo, Drug: Dexamethasone placeboSivelestat sodium placebo and dexamethasone placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet the diagnostic criteria for moderate-to-severe ARDS
- Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS
- ARDS onset to randomized grouping within 72 hours (starting at the time of onset documented in the medical record)
- Patient volunteers to participate in the study and signs an informed consent form
Key exclusion criteria (12 listed)
- Pregnancy or breastfeeding
- brain death
- Advanced cancer or other terminal disease
- History of allergy to Sivelestat Sodium and Dexamethasone
- Severe chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sivelestat sodiumSevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days) | Drug | Sivelestat sodium |
| DexamethasoneDexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days) | Drug | Dexamethasone |
| Sivelestat sodium placeboSivelestat 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 placeboDexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days) | Drug | Placebo, Sivelestat sodium |
Primary outcome
28-day ventilator-free days
Time frame: 28 days after randomization
ventilator-free days within 28 days
Informed consent rate
Time frame: 90 days after randomization
The rate of informed consent
Recruitment rate
Time frame: 90 days after randomization
The rate of recruitment
Recruitment compliance rate
Time frame: 90-day after randomization
The rate of recruitment compliance
Protocol adherence rate
Time frame: 90 days after randomization
The rate of protocol adherence
Completion of follow-up visits
Time frame: 90 days after randomization
The rate of completion of follow-up visits
15 secondary outcomes
28-day mortality
Time frame: 28 days after randomization
90-day mortality
Time frame: 90 days after randomization
28-day length of stay
Time frame: 28 days after randomization
28-day organ support free day
Time frame: 28 days after randomization
Sequential organ failure assessment (SOFA)
Time frame: 14 days after randomization
Murray's acute lung injury score
Time frame: 14 days after randomization
C-reactive protein (CRP)
Time frame: 14 days after randomization
Interleukin-6 (IL-6)
Time frame: 14 days after randomization
Interleukin-8 (IL-8)
Time frame: 14 days after randomization
Procalcitonin (PCT)
Time frame: 14 days after randomization
Neutrophil-to-lymphocyte Ratio (NLR)
Time frame: 14 days after randomization
Neutrophil elastase
Time frame: 14 days after randomization
New-onset infection rate
Time frame: 28 days after randomization
Re-intubation rate
Time frame: 28 days after randomization
Adverse event
Time frame: 28 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared upon proper requirement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Du, MD study chair
Peking Union Medical College
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sivelestat sodium and Dexamethasone in people with Acute Respiratory Distress Syndrome, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Chen (+8613538700762, libby0212@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day ventilator-free days (time frame: 28 days after randomization). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.