Respiratory Infection VirusNCT05697016
Sivelestat for Acute Respiratory Distress Syndrome Due to COVID-19
A study testing Sivelestat Sodium for Injection in people with Respiratory Infection Virus and Respiratory Failure, run by Beijing Tiantan Hospital.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Infection Virus, Respiratory Failure
- What is being tested?
- Sivelestat Sodium for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2023to 31 Jan 2024
- 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
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sivelestat for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome Due to COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial
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)
Read the detailed description
This study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in China from January 1, 2023, to January 31, 2024. During the study period, we intend to enroll a total of 238 eligible patients. These patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or ICU discharge if it occurs before day 7). Both the patients and investigators are blinded to the treatment assignment. Subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. The primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. Also, endpoint assessors are masked to the treatment allocation. Lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for COVID-19-associated ARDS
- Conditions
- Respiratory Infection Virus, Respiratory Failure
- Being tested
- Sivelestat Sodium for Injection, The Placebo
- Keywords
- ARDS, COVID-19, Sivelestat, Randomized Trial
- Medical subject headings
- Respiratory Insufficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat Sodium for InjectionDrug
Also called Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines
Sivelestat, a specific inhibitor of neutrophil elastase; sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl]amino-acetate tetrahydrate]
The PlaceboDrug
Also called Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelines
Excipients used for the sivelestat sodium
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: The Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio
Changes in the PaO2/FiO2 ratio
Measured: From randomization to day 7
Secondary outcomes (4)
Ventilator-Free days
The number of Ventilator-Free Days
Measured: From randomization to day 28
In-hospital mortality
The rate of death during hospitalization
Measured: Through study completion, a period of 28 days
Length of hospitalization
The overall length of hospital stay
Measured: Through study completion, a period of 28 days
Intensive care unit (ICU) length of stay
The time interval between ICU admission and ICU discharge
Measured: Through study completion, a period of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start31 Jan 2023 (estimated)
- Primary completion3 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infection VirusStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangzhi Shi, Beijing Tiantan Hospital
- Investigators
- Guangzhi Shi, M.D., Principal investigator, Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical UniversityZhigang Zhao, M.D., Principal investigator, Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697016
- Sponsor's protocol ID
- HX-B-2022083
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sivelestat for the Treatment of Adult Patients With Acute Respiratory Distress Syndrome Due to COVID-19: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05697016
- Acronym / sponsor ID
- HX-B-2022083
- Conditions
- Respiratory Infection Virus, Respiratory Failure
- Keywords
- ARDS, COVID-19, Sivelestat, Randomized Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Jan 2023 (estimated)
- Primary completion
- 3 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 25 Jan 2023 (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.
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)
Detailed description
This study is designed as a randomized, double-blind, placebo-controlled clinical trial, and is planned to be conducted at 3 clinical centers in China from January 1, 2023, to January 31, 2024. During the study period, we intend to enroll a total of 238 eligible patients. These patients will be randomly assigned in a 1:1 ratio to receive either sivelestat sodium or placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days (or to the day of death or ICU discharge if it occurs before day 7). Both the patients and investigators are blinded to the treatment assignment. Subsequent follow-ups will be performed in person at 7,14 and 28 days after randomization. The primary endpoint will be at 7 days post randomization and secondary endpoints will be at 14 and 28 days post randomization. Also, endpoint assessors are masked to the treatment allocation. Lastly, these endpoint variables will be compared between the treatment groups to investigate the efficacy and safety of sivelestat for COVID-19-associated ARDS
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 |
|---|---|---|
| the Sivelestat group | Experimental | Drug: Sivelestat Sodium for InjectionThe patients in this group will receive sivelestat sodium via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days |
| The Placebo group | Placebo comparator | Drug: The PlaceboThe patients in this group will receive the placebo via continuous intravenous infusion (0.2mg/kg/h) over a 24-hour period for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
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 Sodium for InjectionAlso: Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelinesSivelestat, a specific inhibitor of neutrophil elastase; sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenyl-sulfonylaminobenzoyl]amino-acetate tetrahydrate] | Drug | the Sivelestat group |
| The PlaceboAlso: Supportive management of ARDS (e.g., protective ventilation strategy, prone positioning and/or VV-ECMO, etc.) based on currently recommended practice guidelinesExcipients used for the sivelestat sodium | Drug | The Placebo group |
Primary outcome
PaO2/FiO2 ratio
Time frame: From randomization to day 7
Changes in the PaO2/FiO2 ratio
4 secondary outcomes
Ventilator-Free days
Time frame: From randomization to day 28
In-hospital mortality
Time frame: Through study completion, a period of 28 days
Length of hospitalization
Time frame: Through study completion, a period of 28 days
Intensive care unit (ICU) length of stay
Time frame: Through study completion, a period of 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Guangzhi Shi, M.D. principal investigator
Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University
Zhigang Zhao, M.D. principal investigator
Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Sivelestat Sodium for Injection in people with Respiratory Infection Virus and Respiratory Failure, run by Beijing Tiantan Hospital.
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 5 inclusion and 14 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Jingwei Zhao, M.D. (86-010-59975098, 126-zjw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2/FiO2 ratio (time frame: From randomization to day 7). 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 25 Jan 2023.