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

NCT ID: NCT04345861

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-11

Study Completion Date

2021-04-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronavirus Infection Pneumonia, Viral

Keywords

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SARS-CoV2 virus COVID-19 pneumonia hydroxychloroquine azithromycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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monotherapy hydroxychloroquine

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

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine + placebo

Intervention Type DRUG

hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)

combination hydroxychloroquine + azithromycin

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

Group Type EXPERIMENTAL

hydroxychloroquine + azithromycin

Intervention Type DRUG

Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)

Interventions

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Hydroxychloroquine + placebo

hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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,..
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques REYNES, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

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Montpellier University hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_168

Identifier Type: -

Identifier Source: org_study_id