Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)

University Hospital Center (CHU)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Pneumonia, Viral; Coronavirus Infection

Treatments: Drug: Hydroxychloroquine + placebo; Drug: hydroxychloroquine + azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04345861

RECHMPL20_168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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,..

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups

monotherapy hydroxychloroquine

Active Comparator group

Description:

Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5

Treatment:

Drug: Hydroxychloroquine + placebo

combination hydroxychloroquine + azithromycin

Experimental group

Description:

Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5)

Treatment:

Drug: hydroxychloroquine + azithromycin