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

NCT04345861 | Terminated Phase 2 DMC

• 1 other identifier: RECHMPL20_168
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 hospitalized with confirmed COVID-19 pneumonia.

Conditions

Coronavirus Infection; Pneumonia, Viral

Keywords

SARS-CoV2 virus; COVID-19; pneumonia; hydroxychloroquine; azithromycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical status assessed by ordinal scale

  up to Day 29

• transfer to ICU

  up to Day 29

• Length of hospital day

  up to Day 29

• Hospital Mortality

  Day 29

• Need to Mechanical Ventilation

  up to Day 29

Study Arms (2)

monotherapy hydroxychloroquine

ACTIVE COMPARATOR

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

Drug: Hydroxychloroquine + placebo

combination hydroxychloroquine + azithromycin

EXPERIMENTAL

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

Drug: hydroxychloroquine + azithromycin

Interventions

Hydroxychloroquine + placebo DRUG

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

monotherapy hydroxychloroquine

hydroxychloroquine + azithromycin 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)

combination hydroxychloroquine + azithromycin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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,..

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Coronavirus Infections; Pneumonia, Viral; COVID-19; Pneumonia

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jacques REYNES, MD,PhD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 15, 2020
• Study Start: April 11, 2020
• Primary Completion: February 9, 2021
• Study Completion: April 9, 2021
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)