Acute Respiratory Distress SyndromePhase 4SEVO-COVID19NCT04359862
Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
A Phase 4 study testing Sevoflurane and Propofol in people with Acute Respiratory Distress Syndrome and COVID19 Infection, run by Fundación para la Investigación del Hospital Clínico de Valencia at 5 sites in Spain.
Trial summary
It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study. Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours. Patients will be randomized to one of the treatment groups: SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, COVID19 Infection
- What is being tested?
- Sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesSpain
- Study dates
- 16 Apr 2020to 31 Mar 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more.
- Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
- Signature of Patient's Consent or Verbal Consent of Legal Representative
Who cannot join
- Intracranial hypertension
- Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
- Current volume < 250ml
- History of malignant hyperthermia
- Liver failure
- Neutropenia (<0.5x109)
- Pregnant or lactating women
- Have received chemotherapy in the last month since their inclusion in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario Cruces
Barakaldo, Bizkaia, 48903
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital General Universitario de Valencia
Valencia, 46014
About this study
It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.
Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.
Patients will be randomized to one of the treatment groups:
- SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
- PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
- Being tested
- Sevoflurane, Propofol
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
PropofolDrug
25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
| Study group | Role | What they receive |
|---|---|---|
| SEVOFLURANE Group | Experimental | Not described Receives: Drug: Sevoflurane |
| PROPOFOL Group | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19
Measured: Day 2
Secondary outcomes (5)
TNFα
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Measured: Day 2
IL-1b
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Measured: Day 2
IL-6
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Measured: Day 2
IL-8
To quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19
Measured: Day 2
Mortality
To evaluate the 30-day mortality.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start16 Apr 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Why it stopped: Low recruitment ratio
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
- Model description
- Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359862
- Sponsor's protocol ID
- SEVO-COVID19
- Acronym
- SEVO-COVID19
- Status last verified
- Jul 2021
- First submitted
- 21 Apr 2020
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation With Sevoflurane Versus Propofol in Patients With Acute Respiratory Distress Syndrome Caused by COVID19 Infection
- ClinicalTrials.gov ID
- NCT04359862
- Acronym / sponsor ID
- SEVO-COVID19 / SEVO-COVID19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment ratio
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Apr 2020 (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.
It is a multicenter, national, randomized 1:1 ratio, controlled, parallel, open study.
Patients with severe ARDS-CoVid19 will be included in the trial within the first 24 hours.
Patients will be randomized to one of the treatment groups:
- SEV group: 25 patients with Sevoflurane sedation by inhalation, starting at 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved (BIS 40-50)
- PRO group: 25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, national, randomized, 1:1 ratio, controlled, parallel, open study
| Arm | Type | Receives |
|---|---|---|
| SEVOFLURANE Group | Experimental | Drug: Sevoflurane |
| PROPOFOL Group | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or more.
- Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.
- Signature of Patient's Consent or Verbal Consent of Legal Representative
Key exclusion criteria (8 listed)
- Intracranial hypertension
- Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients
- Current volume < 250ml
- History of malignant hyperthermia
- Liver failure
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 |
|---|---|---|
| Sevoflurane25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50) | Drug | SEVOFLURANE Group |
| Propofol25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50) | Drug | PROPOFOL Group |
Primary outcome
PaO2/FiO2
Time frame: Day 2
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19
5 secondary outcomes
TNFα
Time frame: Day 2
IL-1b
Time frame: Day 2
IL-6
Time frame: Day 2
IL-8
Time frame: Day 2
Mortality
Time frame: Day 30
Results and safety
The study was stopped early (reason given: Low recruitment ratio). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Propofol in people with Acute Respiratory Distress Syndrome and COVID19 Infection, run by Fundación para la Investigación del Hospital Clínico de Valencia at 5 sites in Spain.
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 8 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: stopped early, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
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 was stopped early (reason given: Low recruitment ratio). Results are not available in the source record.
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 (time frame: Day 2). 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 27 Jul 2021.