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

• Status: Terminated
• Trial end date: 2020-06-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Azithromycin; Hydroxychloroquine

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,..