Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial) (COVIDOC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04345861 |
Recruitment Status :
Terminated
(halted prematurely.)
First Posted : April 15, 2020
Last Update Posted : December 15, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Infection Pneumonia, Viral | Drug: Hydroxychloroquine + placebo Drug: hydroxychloroquine + azithromycin | Phase 2 Phase 3 |
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 : | February 9, 2021 |
Actual Study Completion Date : | April 9, 2021 |

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) |
- 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)
- 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
- transfer to ICU [ Time Frame: up to Day 29 ]Necessity for transfer to Intensive care unit
- Length of hospital day [ Time Frame: up to Day 29 ]days from admission to hospital discharge
- Hospital Mortality [ Time Frame: Day 29 ]incidence of all-cause mortality
- Need to Mechanical Ventilation [ Time Frame: up to Day 29 ]Need to mechanical ventilation
- Occurence of grade 3-4 adverse event [ Time Frame: up to Day 29 ]adverse reactions
- QTc Lengthening [ Time Frame: up to Day 11 ]ECG
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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,..

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
France | |
Montpellier University hospital | |
Montpellier, France, 34295 |
Principal Investigator: | Jacques REYNES, MD,PhD | Montpellier University Hospital |
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: | December 15, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV2 virus COVID-19 pneumonia hydroxychloroquine azithromycin |
COVID-19 Pneumonia Coronavirus Infections Pneumonia, Viral Respiratory Tract Infections Infections Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases |
Respiratory Tract Diseases Azithromycin Hydroxychloroquine Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |