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halted prematurely.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monotherapy hydroxychloroquine | Active Comparator | Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5 |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine + placebo | Drug | hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to Day 29 |
| transfer to ICU | Necessity for transfer to Intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques REYNES, MD,PhD | Montpellier University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University hospital | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| 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) |
|
| up to Day 29 |
| Length of hospital day | days from admission to hospital discharge | up to Day 29 |
| Hospital Mortality | incidence of all-cause mortality | Day 29 |
| Need to Mechanical Ventilation | Need to mechanical ventilation | up to Day 29 |
| Occurence of grade 3-4 adverse event | adverse reactions | up to Day 29 |
| QTc Lengthening | ECG | up to Day 11 |
| 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 | up to Day 11 |
| D007239 |
| Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |