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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)
Montpellier University hospital
Montpellier, France
Time to clinical improvement of at least 1 level on the ordinal scale between Day 1 (day of the first administration of study drug) to Day 11 (day after last day of treatment).
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)
Time frame: up to Day 11
Clinical status assessed by ordinal scale
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
Time frame: up to Day 29
transfer to ICU
Necessity for transfer to Intensive care unit
Time frame: up to Day 29
Length of hospital day
days from admission to hospital discharge
Time frame: up to Day 29
Hospital Mortality
incidence of all-cause mortality
Time frame: Day 29
Need to Mechanical Ventilation
Need to mechanical ventilation
Time frame: up to Day 29
Occurence of grade 3-4 adverse event
adverse reactions
Time frame: up to Day 29
QTc Lengthening
ECG
Time frame: up to Day 11
Evolution of pulmonary CT scan images
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Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework
Time frame: up to Day 11