| Methods |
Trial design: open RCT
Sample size: 122
Setting: inpatient
Language: French, English
Number of centres: 18
Type of intervention (treatment/prevention): treatment |
| Participants |
Inclusion criteria
Patient aged > 18 Patient affiliated to a health insurance plan 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 Serum potassium > 3.5 mmol/L Patient diagnosed COVID‐positive by RT‐PCR and/or scanner (patients admitted with already IMV and sedation, or with acute respiratory failure evolving very quickly)
Exclusion criteria
Patient under guardianship or curatorship Patient with plausible alternate diagnosis ARDS evolving for > 4 days Contraindication to hydroxychloroquine Contraindication to dexamethasone Uncontrolled septic shock Untreated active infection or treated < 24 h Long‐term patient treated with corticosteroids (> 20 mg/d) or hydroxychloroquine Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients Pregnant women
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| Interventions |
Details of intervention
Dose: 20 mg dexamethasone + hydroxychloroquine Route of administration: dexamethasone IV, hydroxychloroquine orally Treatment details of control group (e.g. dose, route of administration): hydroxychloroquine
Concomitant therapy: no information |
| Outcomes |
Primary study outcome: mortality on day 28 |
| Notes |
Recruitment status: prematurely ended
Date of the global end of the trial: 7 August 2020
Date last update was posted: unclear
Sponsor/funding: Groupe Hospitalier Paris Saint‐Joseph |
