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

Coronavirus Infection Clinical Trial

— COVIDOC  

Official title:

Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04345861
• Other study ID #: RECHMPL20_168
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 11, 2020
• Est. completion date: April 9, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,..

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Pneumonia
• Pneumonia, Viral

Intervention

Drug:
• Hydroxychloroquine + placebo
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
• hydroxychloroquine + azithromycin
Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)

Locations

Country	Name	City	State
France	Montpellier University hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points (score range from 1 to 7 , with 7 being the worst score)	up to Day 11
Secondary	Clinical status assessed by ordinal scale	Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29	up to Day 29
Secondary	transfer to ICU	Necessity for transfer to Intensive care unit	up to Day 29
Secondary	Length of hospital day	days from admission to hospital discharge	up to Day 29
Secondary	Hospital Mortality	incidence of all-cause mortality	Day 29
Secondary	Need to Mechanical Ventilation	Need to mechanical ventilation	up to Day 29
Secondary	Occurence of grade 3-4 adverse event	adverse reactions	up to Day 29
Secondary	QTc Lengthening	ECG	up to Day 11
Secondary	Evolution of pulmonary CT scan images	Thoracic CT scan : number and size of ground-glass opacifications on day 1 and day 11 Two independent pulmonary imagery experts will assess abnormalities according to a standardized framework	up to Day 11