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

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ClinicalTrials.gov Identifier: NCT04345861
Recruitment Status : Terminated (halted prematurely.)
First Posted : April 15, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Pneumonia, Viral Drug: Hydroxychloroquine + placebo Drug: hydroxychloroquine + azithromycin Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
Actual Study Start Date : April 11, 2020
Actual Primary Completion Date : June 8, 2020
Actual Study Completion Date : June 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: monotherapy hydroxychloroquine
Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5
 Drug: Hydroxychloroquine + placebo
hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
Experimental: 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)
 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)


Outcome Measures
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Primary Outcome Measures :
  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). [ Time Frame: up to Day 11 ]
    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 :
  1. Clinical status assessed by ordinal scale [ Time Frame: up to Day 29 ]
    Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29

  2. transfer to ICU [ Time Frame: up to Day 29 ]
    Necessity for transfer to Intensive care unit

  3. Length of hospital day [ Time Frame: up to Day 29 ]
    days from admission to hospital discharge

  4. Hospital Mortality [ Time Frame: Day 29 ]
    incidence of all-cause mortality

  5. Need to Mechanical Ventilation [ Time Frame: up to Day 29 ]
    Need to mechanical ventilation

  6. Occurence of grade 3-4 adverse event [ Time Frame: up to Day 29 ]
    adverse reactions

  7. QTc Lengthening [ Time Frame: up to Day 11 ]
    ECG

  8. Evolution of pulmonary CT scan images [ Time Frame: up to Day 11 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,..
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04345861


Locations
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France
Montpellier University hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Jacques REYNES, MD,PhD Montpellier University Hospital
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04345861    
Other Study ID Numbers: RECHMPL20_168
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
SARS-CoV2 virus
COVID-19
pneumonia
hydroxychloroquine
azithromycin
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
 Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents