Dexamethasone and oxygen support strategies in ICU patients with Covid-19 pneumonia
- Conditions
- acute hypoxemic respiratory failure (AHRF)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001457-43-FR
- Lead Sponsor
- APHP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 550
1.Age = 18 years
2.Admitted to ICU within 48 hours
3.Confirmed or highly suspected COVID-19 infection
4.Acute hypoxemic respiratory failure (PaO2 <70 mmHg or SpO2<90% on room air or tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow >=6L/min)
5.Any treatment intended to treat the SARS-CoV-2 infection (either as a compassionate use or in the context of a clinical trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity).
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
1. Patient moribond
2. Grossesse ou allaitement
3. Corticothérapie à long terme à une dose de 0,5 mg / kg / j ou plus
4. Infection bactérienne, fongique ou parasitaire active et non traitée
5. Absence de consentement éclairé écrit du patient ou d'un représentant légal, le cas échéant
6. Hypersensibilité à la Dexamethasone ou l’un de ces excipients
Pour les patients non ventilés mécaniquement, les critères de non-inclusion supplémentaires sont:
7. Facteurs anatomiques empêchant l'utilisation d'une canule nasale
8. Hypercapnie indiquant une VNI (paCO2 = 50 mmHg)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method