Sedation with sevoflurane versus propofol in patients with Acute Respiratory Distress Syndrome caused by COVID-19 infectio

Phase 1

• Conditions: Acute Respiratory Distress Syndrome caused by COVID19 infection; MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001379-34-ES
• Lead Sponsor: Instituto de Investigación Sanitaria INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified