Clinical trial NCT04345861: Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
Official title: Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Coronavirus Infection
Pneumonia, Viral
Keywords: SARS-CoV2 virus
COVID-19
pneumonia
hydroxychloroquine
azithromycin
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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,..

Primary outcomes:
measure: 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).
timeFrame: up to Day 11
Secondary outcomes:
measure: Clinical status assessed by ordinal scale
timeFrame: up to Day 29
measure: transfer to ICU
timeFrame: up to Day 29
measure: Length of hospital day
timeFrame: up to Day 29
measure: Hospital Mortality
timeFrame: Day 29
measure: Need to Mechanical Ventilation
timeFrame: up to Day 29
measure: Occurence of grade 3-4 adverse event
timeFrame: up to Day 29
measure: QTc Lengthening
timeFrame: up to Day 11
measure: Evolution of pulmonary CT scan images
timeFrame: up to Day 11
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University hospital
Study officials:
affiliation: Montpellier University Hospital
name: Jacques REYNES, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: