Acute Respiratory Distress SyndromePhase 4TOAWSSNCT04909697
Treatment of ARDS With Sivelestat Sodium
A Phase 4 study testing Sivelestat sodium and Saline in people with Acute Respiratory Distress Syndrome, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Sivelestat sodium and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2022to 6 Oct 2025
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females).
- Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
- Signed written informed consent has been obtained
Who cannot join
- History of chronic respiratory disease
- Single cardiogenic pulmonary edema
- Apach2 score ≥21 points
- Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
- ARDS course>3 days
- Agranulocytosis or receiving immunosuppressive agents or high doses of corticosteroids (methylprednisolone>40mg/day)
Show all 9Show fewer
- Pregnancy or breastfeeding
- Participated in this study
- Do not agree to participate in this experiment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Sivelestat sodium, Saline
- Keywords
- Acute Respiratory Distress Syndrome
- 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
4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
SalineDrug
50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Saline | Sham comparator | Not described Receives: Drug: Saline |
| Sivelestat Sodium | Experimental | Not described Receives: Drug: Sivelestat sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation improvement rate
Measured: day 3
Secondary outcomes (22)
28-day ventilator-free days
The 28-day VFDs is defined as the number of study days that the patient is alive and off mechanical ventilation after successful weaning. If a patient dies within 28 days, the VFD is recorded as 0.
Measured: day 28
Invasive mechanical ventilation rate
Measured: day 28
length of stay in ICU
Measured: day 28
length of stay in hospital
Measured: day 28
28 days mortality
Measured: day 28
ICU mortality
Measured: day 28
Incidence of acquired infections
Measured: day 28
oxygenation improvement rate
Measured: day 1
oxygenation improvement rate
Measured: day 5
incidence of severe adverse effect
Measured: day 28
activity of neutrophil elastase in plasma
Measured: day0
activity of neutrophil elastase in plasma
Measured: day 1
activity of neutrophil elastase in plasma
Measured: day 3
activity of neutrophil elastase in plasma
Measured: day 5
concentration of IL-6
Measured: day 0
concentration of IL-6
Measured: day 1
concentration of IL-6
Measured: day 3
concentration of IL-6
Measured: day 5
concentration of IL-10
Measured: day 0
concentration of IL-10
Measured: day 1
concentration of IL-10
Measured: day 3
concentration of IL-10
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start18 Apr 2022
- Primary completion13 Sep 2025
- Study completion6 Oct 2025
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Hongli, Sichuan Provincial People's Hospital
- Investigators
- Xiaobo Huang, MD, Principal investigator, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909697
- Sponsor's protocol ID
- SichuanPPHospital
- Acronym
- TOAWSS
- Status last verified
- Apr 2026
- First submitted
- 20 May 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentifed individual participant data are available after the article is published. Data can be accessed with the approval of the authors. Request for data can be made to the corresponding author (drhuangxb@163.com and panchun1982@gmail.com) and will be discussed during a meeting including investigators from all paticipating centers
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Sivelestat Sodium in the Treatment of ARDS With SIRS, a Multicenter Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04909697
- Acronym / sponsor ID
- TOAWSS / SichuanPPHospital
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 2 Jun 2021 (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.
Neutrophil elastase (NE) released by neutrophils play an important role in inflammatory cascade and lung tissue injury of ARDS.Inhibition of NE is expected to prevent the pathophysiological process of ARDS and alleviate lung injury. Siverestat sodium is a specific inhibitor of NE, which has been proved by basic and observational clinical studies to be effective in alleviating lung injury of ARDS, but there is a lack of prospective multi-center randomized controlled clinical trials.Therefore, this study was intended to evaluate the efficacy of sivelestat sodium in the treatment of ARDS patients with SIRS in a multicenter randomized controlled clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Sham comparator | Drug: Saline |
| Sivelestat Sodium | Experimental | Drug: Sivelestat sodium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females > 18 years old and <75 years old (non-pregnant, non-lactating females).
- Patients fulfilled the Berlin diagnostic criteria of acute respiratory distress syndrome, with a arterial oxygen partial pressure (PaO2) to fraction of inspired oxygen (FiO2) between 150 mmHg and 300 mmHg.
- Signed written informed consent has been obtained
Key exclusion criteria (9 listed)
- History of chronic respiratory disease
- Single cardiogenic pulmonary edema
- Apach2 score ≥21 points
- Complicated with end-stage disease, or poor prognosis judged by the clinical doctor in charge
- ARDS course>3 days
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 sodium4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days | Drug | Sivelestat Sodium |
| Saline50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days | Drug | Saline |
Primary outcome
oxygenation improvement rate
Time frame: day 3
22 secondary outcomes
28-day ventilator-free days
Time frame: day 28
Invasive mechanical ventilation rate
Time frame: day 28
length of stay in ICU
Time frame: day 28
length of stay in hospital
Time frame: day 28
28 days mortality
Time frame: day 28
ICU mortality
Time frame: day 28
Incidence of acquired infections
Time frame: day 28
oxygenation improvement rate
Time frame: day 1
oxygenation improvement rate
Time frame: day 5
incidence of severe adverse effect
Time frame: day 28
activity of neutrophil elastase in plasma
Time frame: day0
activity of neutrophil elastase in plasma
Time frame: day 1
activity of neutrophil elastase in plasma
Time frame: day 3
activity of neutrophil elastase in plasma
Time frame: day 5
concentration of IL-6
Time frame: day 0
concentration of IL-6
Time frame: day 1
concentration of IL-6
Time frame: day 3
concentration of IL-6
Time frame: day 5
concentration of IL-10
Time frame: day 0
concentration of IL-10
Time frame: day 1
concentration of IL-10
Time frame: day 3
concentration of IL-10
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Deidentifed individual participant data are available after the article is published. Data can be accessed with the approval of the authors. Request for data can be made to the corresponding author (drhuangxb@163.com and panchun1982@gmail.com) and will be discussed during a meeting including investigators from all paticipating centers
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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.
Xiaobo Huang, MD principal investigator
Sichuan Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sivelestat sodium and Saline in people with Acute Respiratory Distress Syndrome, run by Sichuan Provincial People's Hospital at 1 site 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation improvement rate (time frame: day 3). 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 May 2026.