Sevoflurane in COVID-19 ARDS (SevCov)

University of Zurich (UZH)

Status and phase: Completed; Phase 3

Conditions: ARDS, Human; Coronavirus

Treatments: Drug: Sevoflurane; Drug: Intravenous drug

Study type: Interventional

Funder types: Other

Identifiers

NCT04355962

2020-00719

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)
• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

Sevoflurane Sedation

Experimental group

Description:

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

Treatment:

Drug: Sevoflurane

Intravenous

Active Comparator group

Description:

No use of sevoflurane, but current intravenous sedation at discretion of the ICU physician in charge, e.g. with propofol, fentanyl, midazolam and dexmedetomidine

Treatment:

Drug: Intravenous drug