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.
Drug: Hydroxychloroquine + placebo
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
Drug: hydroxychloroquine + azithromycin
Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)
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,..
Montpellier University hospital
Montpellier, France
Jacques REYNES, MD,PhD, Principal Investigator
Montpellier University Hospital