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

Last updated: December 14, 2021
Sponsor: University Hospital, Montpellier
Overall Status: Terminated

Phase

2/3

Condition

Pneumonia

Common Cold

Respiratory Syncytial Virus (Rsv) Infection

Treatment

N/A

Clinical Study ID

NCT04345861
RECHMPL20_168
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised inthe 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 respiratorysign(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

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,..

Study Design

Total Participants: 7
Study Start date:
April 11, 2020
Estimated Completion Date:
April 09, 2021

Study 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.

Connect with a study center

  • Montpellier University hospital

    Montpellier, 34295
    France

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.