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

Primary Purpose

Coronavirus Infection, Pneumonia, Viral

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Hydroxychloroquine + placebo
hydroxychloroquine + azithromycin
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring SARS-CoV2 virus, COVID-19, pneumonia, hydroxychloroquine, azithromycin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,..

Sites / Locations

  • Montpellier University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

monotherapy hydroxychloroquine

combination hydroxychloroquine + azithromycin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
transfer to ICU
Necessity for transfer to Intensive care unit
Length of hospital day
days from admission to hospital discharge
Hospital Mortality
incidence of all-cause mortality
Need to Mechanical Ventilation
Need to mechanical ventilation
Occurence of grade 3-4 adverse event
adverse reactions
QTc Lengthening
ECG
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

Full Information

First Posted
April 5, 2020
Last Updated
December 14, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04345861
Brief Title
Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
Acronym
COVIDOC
Official Title
Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
halted prematurely.
Study Start Date
April 11, 2020 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection, Pneumonia, Viral
Keywords
SARS-CoV2 virus, COVID-19, pneumonia, hydroxychloroquine, azithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
monotherapy hydroxychloroquine
Arm Type
Active Comparator
Arm Description
Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5
Arm Title
combination hydroxychloroquine + azithromycin
Arm Type
Experimental
Arm Description
Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) and azithromycin 500mg (Day 1 ), 250 mg (from day 2 to Day 5)
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine + placebo
Intervention Description
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine + azithromycin
Intervention Description
Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)
Primary Outcome Measure Information:
Title
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).
Description
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)
Time Frame
up to Day 11
Secondary Outcome Measure Information:
Title
Clinical status assessed by ordinal scale
Description
Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29
Time Frame
up to Day 29
Title
transfer to ICU
Description
Necessity for transfer to Intensive care unit
Time Frame
up to Day 29
Title
Length of hospital day
Description
days from admission to hospital discharge
Time Frame
up to Day 29
Title
Hospital Mortality
Description
incidence of all-cause mortality
Time Frame
Day 29
Title
Need to Mechanical Ventilation
Description
Need to mechanical ventilation
Time Frame
up to Day 29
Title
Occurence of grade 3-4 adverse event
Description
adverse reactions
Time Frame
up to Day 29
Title
QTc Lengthening
Description
ECG
Time Frame
up to Day 11
Title
Evolution of pulmonary CT scan images
Description
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
Time Frame
up to Day 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,..
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques REYNES, MD,PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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