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ARDS, HumanPhase 3NCT04355962

Sevoflurane in COVID-19 ARDS (SevCov)

A Phase 3 study testing Sevoflurane and Intravenous drug in people with ARDS, Human and Coronavirus, run by University of Zurich at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission in the population of patients suffering from COVID-19 ARDS. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
ARDS, Human, Coronavirus
What is being tested?
Sevoflurane and Intravenous drug
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
4 sitesSwitzerland
Study dates
23 Apr 2020to 16 Jul 2021
Phase
Phase 3
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • SARS-CoV-2 infection (positive testing) or computed tomography (CT) scan-suspected COVID-19 ARDS
  • Male and female patients, age 18 to 85 years
  • ICU patients with ARDS defined as PaO2/FiO2 < 200mmHg (=26.6kPa)
  • Time of intubation not longer than 24 hours
  • QTc Time (ECG) not longer than 470 ms ♂ (male)/ 480 ms ♀ (female)
  • Sedation and mechanical ventilation in ICU
  • Informed consent, signed by a representative or by an independent physician

Who cannot join

  • High dose systemic corticosteroids in the phase before hospitalization (> 10mg/d prednisone or equivalent dose)
  • Significant concomitant disease (acute cerebral vascular event, acute coronary syndrome, seizure, burn, neuromuscular disease)
  • Organ transplant
  • AIDS
  • Pregnancy and/or breastfeeding
  • Use of cytokine absorber

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Kantonsspital Münsterlingen

    Münsterlingen, 8596

  • Cantonal Hospital of St. Gallen

    Sankt Gallen, 9007

  • Stadtspital Triemli

    Zurich, 8063

  • University Hospital Zuirch

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: Sevoflurane Sedation in COVID-19 ARDS Patients to Reduce Lung Injury: a Randomized Controlled Trial

The purpose of this trial is to study the effect of initial temporary sevoflurane sedation on mortality and persistent organ dysfunction (POD) in survivors at day 28 after ICU admission in the population of patients suffering from COVID-19 ARDS.

Read the detailed description

The corona virus disease 19 (COVID-19) pandemic, caused by the severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is spreading rapidly across Europe. While data from European centers are still missing, several publications from Chinese centers are available. Respiratory failure from acute respiratory distress syndrome (ARDS) is the leading cause of mortality, and may be caused or exacerbated by a 'cytokine storm syndrome'.

Recent trials from our group demonstrated that the volatile anesthetic sevoflurane administered during ventilation of patients has anti-inflammatory properties. Moreover, in in vivo studies volatile anesthetics reduce the severity of ARDS compared to intravenous sedation, which has been confirmed in a clinical pilot trial. Attenuating ARDS and thereby improving oxygenation strongly decreases morbidity and mortality of patients.

Being tested
Sevoflurane, Intravenous drug
Keywords
COVID-19, ARDS
Medical subject headings
Respiratory Distress Syndrome, Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS

  • Intravenous drugDrug

    Intravenous sedation in control group will be continued as initiated at the ICU e.g. propofol, fentanyl, midazolam, dexmedetomidine

Study groups in NCT04355962
Study groupRoleWhat they receive
Sevoflurane SedationExperimentalSedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS
Receives: Drug: Sevoflurane
IntravenousActive comparatorNo use of sevoflurane, but current intravenous sedation at discretion of the ICU physician in charge, e.g. with propofol, fentanyl, midazolam and dexmedetomidine
Receives: Drug: Intravenous drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome of death rate (rate of patients that did not survive) and organ failure rate (rate of patients surviving with persistent organ dysfunction) at day 28

    The effect of sevoflurane application on mortality (rate of patients that does not survive 28 days) and persistent organ dysfunction (rate of patients surviving with a persistent organ failure at day 28) will be assessed. Organ failures are defined as pulmonary failure (necessity of ventilation); cardiovascular failure (need of vasopressors), retail failure (need of renal replacement therapy)

    Measured: 28 days

Secondary outcomes (4)

  1. Length of stay ICU

    The effect of sevoflurane application on the length of stay at ICU will be determined.

    Measured: 28 days

  2. Plasma Inflammatory markers

    The impact of sevoflurane on the course of inflammatory markers will be evaluated (pro-calcitonin, PCT; c-reactive protein, CRP; interleukin 6, IL-6; monocyte chemoattractant protein 1, MCP-1)

    Measured: 8 days

  3. Length of stay at hospital

    The effect of sevoflurane application on the length of stay at hospital will be determined.

    Measured: 28 days

  4. Sex-related differences in complications

    Sex-related differences in complications will be assessed

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start23 Apr 2020
  3. Primary completion25 Jun 2021
  4. Study completion16 Jul 2021

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized, controlled multi-center trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04355962
Sponsor's protocol ID
2020-00719
Status last verified
Jul 2021
First submitted
26 Mar 2020
Last updated
19 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

    PubMed 32091533

  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.

    PubMed 32031570

  • Xie J, Tong Z, Guan X, Du B, Qiu H, Slutsky AS. Critical care crisis and some recommendations during the COVID-19 epidemic in China. Intensive Care Med. 2020 May;46(5):837-840. doi: 10.1007/s00134-020-05979-7. Epub 2020 Mar 2. No abstract available.

    PubMed 32123994

  • Suter D, Spahn DR, Blumenthal S, Reyes L, Booy C, Z'graggen BR, Beck-Schimmer B. The immunomodulatory effect of sevoflurane in endotoxin-injured alveolar epithelial cells. Anesth Analg. 2007 Mar;104(3):638-45. doi: 10.1213/01.ane.0000255046.06058.58.

    PubMed 17312223

  • Yue T, Roth Z'graggen B, Blumenthal S, Neff SB, Reyes L, Booy C, Steurer M, Spahn DR, Neff TA, Schmid ER, Beck-Schimmer B. Postconditioning with a volatile anaesthetic in alveolar epithelial cells in vitro. Eur Respir J. 2008 Jan;31(1):118-25. doi: 10.1183/09031936.00046307. Epub 2007 Sep 26.

    PubMed 17898018

  • Beck-Schimmer B, Schadde E, Pietsch U, Filipovic M, Dubendorfer-Dalbert S, Fodor P, Hubner T, Schuepbach R, Steiger P, David S, Kruger BD, Neff TA, Schlapfer M. Early sevoflurane sedation in severe COVID-19-related lung injury patients. A pilot randomized controlled trial. Ann Intensive Care. 2024 Mar 27;14(1):41. doi: 10.1186/s13613-024-01276-4.

    PubMed 38536545

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sevoflurane and Intravenous drug in people with ARDS, Human and Coronavirus, run by University of Zurich at 4 sites in Switzerland.

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 7 inclusion and 6 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 19 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 4 sites in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Composite outcome of death rate (rate of patients that did not survive) and organ failure rate (rate of patients surviving with persistent organ dysfunction) at day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04355962, which also lists 6 linked publications.

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 19 Jul 2021.

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