Sevoflurane in COVID-19 ARDS (SevCov)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2021-07-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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ARDS, Human Coronavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized, controlled multi-center trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

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Sevoflurane Sedation

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

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Intravenous drug

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

Intravenous drug

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No