Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-31 @ 1:59 PM
Study NCT ID:
NCT04345861
Status:
TERMINATED
Last Update Posted:
2021-12-15
First Post:
2020-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'halted prematurely.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2020-04-05', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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).', 'timeFrame': 'up to Day 11', '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)'}], 'secondaryOutcomes': [{'measure': 'Clinical status assessed by ordinal scale', 'timeFrame': 'up to Day 29', 'description': 'Evaluation of the clinical status of patient defined by the Ordinal Scale of 7 points at day 15 and day 29'}, {'measure': 'transfer to ICU', 'timeFrame': 'up to Day 29', 'description': 'Necessity for transfer to Intensive care unit'}, {'measure': 'Length of hospital day', 'timeFrame': 'up to Day 29', 'description': 'days from admission to hospital discharge'}, {'measure': 'Hospital Mortality', 'timeFrame': 'Day 29', 'description': 'incidence of all-cause mortality'}, {'measure': 'Need to Mechanical Ventilation', 'timeFrame': 'up to Day 29', 'description': 'Need to mechanical ventilation'}, {'measure': 'Occurence of grade 3-4 adverse event', 'timeFrame': 'up to Day 29', 'description': 'adverse reactions'}, {'measure': 'QTc Lengthening', 'timeFrame': 'up to Day 11', 'description': 'ECG'}, {'measure': 'Evolution of pulmonary CT scan images', 'timeFrame': 'up to Day 11', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV2 virus', 'COVID-19', 'pneumonia', 'hydroxychloroquine', 'azithromycin'], 'conditions': ['Coronavirus Infection', 'Pneumonia, Viral']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised in the 96 h before randomization\n* Beginning of COVID-19 symptoms \\< 10 days at the time of randomization\n* Presence of symptom(s) of COVID-19 : fever (température \\> or = 37,5°C) or respiratory sign(s) (cough, breathing discomfort) or recent anosmia\n* Presence of TDM/radiographic signs or pneumonia\n* Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy) or non critical severe form (oxygenotherapy)\n\nExclusion Criteria:\n\n* Absence of signed informed consent\n* SpO2 \\< 90 % ambient air or \\< 94 % with oxygenotherapy \\> or = 3l/min\n* Need of oxygenotherapy \\> 6 l/min or mechanical ventilation\n* Need of hospitalization in ICU\n* ALAT/ASAT \\> 5 LSN\n* Renal failure (eGFR \\< 40 ml/min ) or dialysis\n* Pregnancy or breastfeeding\n* Retinopathy\n* Known deficit in G6PD\n* Cardiac rythm / lengthening QT disorders\n* QT space lengthening on ECG with QTc \\> 450 ms\n* Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine, anti-arhythmic class IA \\& III, antidepressive drugs,..'}, 'identificationModule': {'nctId': 'NCT04345861', 'acronym': 'COVIDOC', 'briefTitle': 'Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia', 'orgStudyIdInfo': {'id': 'RECHMPL20_168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'monotherapy hydroxychloroquine', 'description': 'Hydroxychloroquine 800mg (Day 1), 600mg (from Day 2 to Day 10) + placebo from Day 1 to Day 5', 'interventionNames': ['Drug: Hydroxychloroquine + placebo']}, {'type': 'EXPERIMENTAL', 'label': 'combination hydroxychloroquine + azithromycin', '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)', 'interventionNames': ['Drug: hydroxychloroquine + azithromycin']}], 'interventions': [{'name': 'Hydroxychloroquine + placebo', 'type': 'DRUG', 'description': 'hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)', 'armGroupLabels': ['monotherapy hydroxychloroquine']}, {'name': 'hydroxychloroquine + azithromycin', 'type': 'DRUG', '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)', 'armGroupLabels': ['combination hydroxychloroquine + azithromycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Montpellier University hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jacques REYNES, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}