ARDS Due to Disease Caused by SARS Co-V-2NCT06218862
Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19
An observational study of ARDS Due to Disease Caused by SARS Co-V-2, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The goal of this retrospective multicentre cohort study is to examine the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS Due to Disease Caused by SARS Co-V-2
- What is being tested?
- Sivelestat sodium
- Type of treatment
- Injection or infusion
- How many people
- 387 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 May 2023
- Phase
- Observational
- 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
Study population: We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China.
Who may be able to join
- 1) equal to or more than 18 years old, 2) had positive COVID-19 reverse transcriptase-polymerase chain reaction test results from upper airway swab, 3) fulfilled the Berlin definition of ARDS
Who cannot join
- pregnant or lactating women, those with concomitant severe chronic respiratory diseases or end-stage malignant tumours, patients with duration of hospital stay or sivelestat administration less than 72 hours and patients for whom complete outcome data were not available.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this retrospective multicentre cohort study is to examine the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
Read the detailed description
We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days.The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
- Being tested
- Sivelestat sodium, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sivelestat sodiumDrug
Also called antiviral
Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for at least 72 hours and a maximum duration of 14 days.
ControlDrug
Also called antiviral
Not use Sivelestat sodium
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat sodium | Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days. Receives: Drug: Sivelestat sodium | |
| Control | Not use Sivelestat sodium Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio on Day 3.
PaO2/FiO2 ratio on Day 3.
Measured: 3 days
Secondary outcomes (2)
28-day mortality
28-day mortality
Measured: 28 days
non-mechanical ventilation time within 28 days
non-mechanical ventilation time within 28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Dec 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to Disease Caused by SARS Co-V-2Studies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuting Li, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218862
- Sponsor's protocol ID
- liyuting@jlu.edu.cn
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Sivelestat Sodium on Improving ARDS in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT06218862
- Acronym / sponsor ID
- liyuting@jlu.edu.cn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 23 Jan 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 retrospective multicentre cohort study is to examine the association between receipt of sivelestat and improvement in oxygenation among patients with acute respiratory distress syndrome (ARDS) induced by COVID-19. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
Detailed description
We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China. We used propensity score matching to compare the outcomes of patients treated with sivelestat to those who were not. Sivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days.The primary outcome was the PaO2/FiO2 ratio on Day 3. Secondary outcomes included 28-day mortality, alive and ICU-free days within 28 days, non-mechanical ventilation time within 28 days, the lengths of stay in the ICU and hospital, proportion of patients requiring extracorporeal membrane oxygenation (ECMO), proportion of patients undergoing endotracheal intubation or tracheotomy, and incidence of adverse events (AEs) or severe adverse events (SAEs).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sivelestat sodium | – | Drug: Sivelestat sodiumSivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for a maximum duration of 14 days. |
| Control | – | Drug: ControlNot use Sivelestat sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We conducted a retrospective cohort study of patients admitted between December 2022 and May 2023 to general ICUs, respiratory ICUs and emergency ICUs across 14 hospitals in Jilin Province, China.
Key inclusion criteria (1 listed)
- 1) equal to or more than 18 years old, 2) had positive COVID-19 reverse transcriptase-polymerase chain reaction test results from upper airway swab, 3) fulfilled the Berlin definition of ARDS
Key exclusion criteria (1 listed)
- pregnant or lactating women, those with concomitant severe chronic respiratory diseases or end-stage malignant tumours, patients with duration of hospital stay or sivelestat administration less than 72 hours and patients for whom complete outcome data were not available.
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 sodiumAlso: antiviralSivelestat sodium was administered through a 24-hour continuous intravenous infusion at a rate of 0.2 mg/kg/h, for at least 72 hours and a maximum duration of 14 days. | Drug | Sivelestat sodium |
| ControlAlso: antiviralNot use Sivelestat sodium | Drug | Control |
Primary outcome
PaO2/FiO2 ratio on Day 3.
Time frame: 3 days
PaO2/FiO2 ratio on Day 3.
2 secondary outcomes
28-day mortality
Time frame: 28 days
non-mechanical ventilation time within 28 days
Time frame: 28 days
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 23 Jan 2024.
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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.
Yuting Li principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS Due to Disease Caused by SARS Co-V-2, run by The First Hospital of Jilin University 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 1 inclusion and 1 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 23 Jan 2024. 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. 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?
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?
PaO2/FiO2 ratio on Day 3. (time frame: 3 days). 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 23 Jan 2024.