Status:
TERMINATED
Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Coronavirus Infection
Pneumonia, Viral
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 hospitaliz...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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,..
Key Trial Info
Start Date :
April 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04345861
Start Date
April 11 2020
End Date
April 9 2021
Last Update
December 15 2021
Active Locations (1)
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1
Montpellier University hospital
Montpellier, France, 34295