Dexamethasone associated with hydroxychloroquine vs. hydroxychloroquine alone for the early treatment of severe ARDS caused by COVID-19 : a randomized controlled trial

Phase 1

• Conditions: Acute Respiratory Distress Syndrome (ARDS) caused by SARS-Cov-2 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001333-13-FR
• Lead Sponsor: Groupe Hospitalier Paris Saint-Joseph

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-02
• Last Update Posted: 18 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Assess, in patients with ARDS causedd by COVID-19, the efficacy of DXM associated with HCQ compared to HCQ alone on :<br>- the ventilator-free days<br>- mortality in intensive care unit<br>- mortality on D60<br>- the occurrence of infectious complications ;Primary end point(s): Mortality on D28<br>;Timepoint(s) of evaluation of this end point: the 28th day after the start of treatment<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Ventilator-free days<br>- Mortality in intensive care unit<br>- Mortality on D60<br>- 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<br>than every 7 days until UCI discharge<br>than D60