acute hypoxemic respiratory failure (AHRF)
Conditions
Interventions
Trade Name: Dexamethasone 20 mg/5mL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
APHP
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the impact of dexamethasone on overall mortality at day-60 after randomization in patients admitted in ICU for severe COVID-19 infection. In non mechanical ventilation (MV) patients, the additional objective is to assess whether oxygen support based on either HFNO or CPAP modality in COVID-19 related AHRF reduces the need for mechanical ventilation at day-28. ;Secondary Objective: For the study of the effect of corticosteroids, secondary objectives include: 1.To compare the evolution of the viral load in the respiratory tract 2.To compare the occurrence of healthcare-associated infections 3.To compare the exposition to mechanical ventilation 4.To compare the evolution of SOFA score 5.To compare the exposition to renal replacement therapy 6.To compare the lengths of ICU and hospital-stay For the study of the effect of oxygen support modalities, secondary objectives are, to compare each of oxygen support group to the control group in terms of: 1.overall survival 2.occurrence of healthcare-associated infections 3.length of ICU and hospital-stay ;Primary end point(s): , the primary endpoint is the time-to-death from all causes within the first 60 days after randomization.and the time to need for mechanical ventilation (MV);Timepoint(s) of evaluation of this end point: october 2020 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin 2.Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28 3.Number of days alive without mechanical ventilation at day 28 5.Number of days alive without renal replacement therapy at day 28;Timepoint(s) of evaluation of this end point: OCTOBER2 020 | — |
Countries
France
Contacts
Public ContactDRCI
APHP
Outcome results
None listed