Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)

Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

Double blinded randomized clinical trial designed to evaluate the efficacy and safety of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with confirmed COVID-19 pneumonia.

The multi-centre COVIDOC study will evaluate the efficacy and safety of the use of hydroxychloroquine (10 days) combined with azithromycin (5 days) compared to hydroxychloroquine (10 days) in the the clinical evolution by the ordinal scale of 7 points in adults hospitalized outside Intensive care unit with pneumonia caused by infection by the SARS-CoV2 virus in France.

Inclusion Criteria:

• 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization
• Beginning of COVID-19 symptoms < 10 days at the time of randomization
• Presence of symptom(s) of COVID-19 : fever (température > or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia
• Presence of TDM/radiographic signs or pneumonia
• Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)

Exclusion Criteria:

• Absence of signed informed consent
• SpO2 < 90 % ambient air or < 94 % with oxygenotherapy > or = 3l/min
• Need of oxygenotherapy > 6 l/min or mechanical ventilation
• Need of hospitalization in ICU
• ALAT/ASAT > 5 LSN
• Renal failure (eGFR < 40 ml/min ) or dialysis
• Pregnancy or breastfeeding
• Retinopathy
• Known deficit in G6PD
• Cardiac rythm / lengthening QT disorders
• QT space lengthening on ECG with QTc > 450 ms
• Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA & III, antidepressive drugs,..