Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
- Conditions
- Coronavirus InfectionPneumonia, Viral
- Interventions
- Registration Number
- NCT04345861
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
- 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)
- 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,..
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description monotherapy hydroxychloroquine Hydroxychloroquine + placebo Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5 combination hydroxychloroquine + azithromycin hydroxychloroquine + azithromycin Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5)
- Primary Outcome Measures
Name Time Method 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). up to Day 11 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)
- Secondary Outcome Measures
Name Time Method QTc Lengthening up to Day 11 ECG
Occurence of grade 3-4 adverse event up to Day 29 adverse reactions
Length of hospital day up to Day 29 days from admission to hospital discharge
Hospital Mortality Day 29 incidence of all-cause mortality
Need to Mechanical Ventilation up to Day 29 Need to mechanical ventilation
Clinical status assessed by ordinal scale up to Day 29 Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
transfer to ICU up to Day 29 Necessity for transfer to Intensive care unit
Evolution of pulmonary CT scan images up to Day 11 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
Trial Locations
- Locations (1)
Montpellier University hospital
🇫🇷Montpellier, France