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Sevoflurane in COVID-19 ARDS (SevCov)

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ClinicalTrials.gov Identifier: NCT04355962
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
ARDS, Human Coronavirus Drug: Sevoflurane Drug: Intravenous drug Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized, controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Patients will not be informed about their group assignments, technicians processing the samples will not have any access to the ICU or the patient chart (= double-blind trial). Due to the procedures involved in volatile versus intravenous sedation, group assignment cannot be entirely concealed for the study staff and ICU doctors/nurses involved with the procedure in the ICU (pragmatic limits of blinding).
Primary Purpose: Treatment
Official Title: Sevoflurane Sedation in COVID-19 ARDS Patients to Reduce Lung Injury: a Randomized Controlled Trial
Actual Study Start Date : April 23, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Experimental: Sevoflurane Sedation
Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS
Drug: Sevoflurane
Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS

Active Comparator: Intravenous
No use of sevoflurane, but current intravenous sedation at discretion of the ICU physician in charge, e.g. with propofol, fentanyl, midazolam and dexmedetomidine
Drug: Intravenous drug
Intravenous sedation in control group will be continued as initiated at the ICU e.g. propofol, fentanyl, midazolam, dexmedetomidine




Primary Outcome Measures :
  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 [ Time Frame: 28 days ]
    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)


Secondary Outcome Measures :
  1. Length of stay ICU [ Time Frame: 28 days ]
    The effect of sevoflurane application on the length of stay at ICU will be determined.

  2. Plasma Inflammatory markers [ Time Frame: 8 days ]
    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)

  3. Length of stay at hospital [ Time Frame: 28 days ]
    The effect of sevoflurane application on the length of stay at hospital will be determined.

  4. Sex-related differences in complications [ Time Frame: 28 days ]
    Sex-related differences in complications will be assessed



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Onset of ARDS not longer than 24 hours
  • Sedation and mechanical ventilation in ICU
  • Informed consent, signed by a representative or by an independent physician

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355962


Contacts
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Contact: Martin Schläpfer, PD +41442554690 ext +41442554690 martin.schlaepfer@usz.ch
Contact: Beatrice Beck Schimmer, Prof +41442551111 ext +41442551111 beatrice.beck@usz.ch

Locations
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Switzerland
University Hospital Zuirch Recruiting
Zurich, Switzerland, 8091
Contact: Martin H Schläpfer, PD MD    +41442554690 ext +41442554690    martin.schlaepfer@usz.ch   
Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Beatrice Beck Schimmer, Prof University of Zurich
Publications:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04355962    
Other Study ID Numbers: 2020-00719
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
COVID-19
ARDS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs