Acute Respiratory Distress Syndrome (ARDS) caused by SARS-Cov-2 infection
Conditions
Interventions
Trade Name: DEXAMETHASONE MYLAN 20mg/5mL
Product Name: DEXAMETHASONE
Pharmaceutical Form: Injection
Trade Name: PLAQUENIL 200MG
Product Name: HYDROXYCHLOROQUINE
Pharmaceutical Form: Tablet
Sponsors
Groupe Hospitalier Paris Saint-Joseph
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient aged > 18 2. Patient affiliated to a health insurance plan 3. Patient who has given their free, informed and written consent or patient for whom an independent doctor has given their signed consent as part of an emergency procedure 4. Serum Potassium> 3,5 mmol / L 5. Patient diagnosed COVID positive by RT-PCR and / or scanner 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42
Exclusion criteria
Exclusion criteria: 1. Patient under guardianship or curatorship 2. Patient with plausible alternate diagnosis 3. ARDS evolving for more than 4 days 4. Contraindication to the HCQ 5. Contraindication to DXM 6. Uncontrolled septic shock 7. Untreated active infection or treated less than 24 hours 8. Long-term patient treated with corticosteroids (> 20 mg / day) or HCQ 9. Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Assess, in patients with ARDS causedd by COVID-19, the efficacy of DXM associated with HCQ compared to HCQ alone on : - the ventilator-free days - mortality in intensive care unit - mortality on D60 - the occurrence of infectious complications ;Primary end point(s): Mortality on D28 ;Timepoint(s) of evaluation of this end point: the 28th day after the start of treatment ;Main Objective: Assess, in patients with ARDS caused by COVID-19, the efficacy of dexamethasone (DXM) associated with hydroxychloroquine (HCQ) compared to HCQ alone on mortality at 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Ventilator-free days - Mortality in intensive care unit - Mortality on D60 - Number of episodes of pneumonia and bacteremia;Timepoint(s) of evaluation of this end point: Days 1, 3, 6 , 10 after the start of the treatment than every 7 days until UCI discharge than D60 | — |
Countries
France
Contacts
Public ContactClinical research project manager
Groupe Hospitalier Paris Saint Joseph - Hôpital Marie Lannelongue
Outcome results
None listed