EUCTR2020-001457-43-FRActive, not recruitingPhase 1
Dexamethasone and oxygen support strategies in ICU patients with Covid-19 pneumonia - COVIDICUS
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- APHP
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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