Coronavirus Infection, Pneumonia, Viral
Conditions
Keywords
SARS-CoV2 virus, COVID-19, pneumonia, hydroxychloroquine, azithromycin
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.
Interventions
DRUGHydroxychloroquine + placebo
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)
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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,..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| transfer to ICU | up to Day 29 | Necessity for transfer to Intensive care unit |
| Length of hospital day | up to Day 29 | days from admission to hospital discharge |
| Hospital Mortality | Day 29 | incidence of all-cause mortality |
| 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 |
| Occurence of grade 3-4 adverse event | up to Day 29 | adverse reactions |
| QTc Lengthening | up to Day 11 | ECG |
| 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 |
| Need to Mechanical Ventilation | up to Day 29 | Need to mechanical ventilation |
Countries
France
Outcome results
None listed