Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04347512
Status:
WITHDRAWN
Last Update Posted:
2020-06-04
First Post:
2020-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'In view of the notices concerning hydroxychloroquine issued by the regulatory authorities, we withdraw the protocol', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2020-04-11', 'studyFirstSubmitQcDate': '2020-04-11', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients reaching a significant hypoxemia, in each arms.', 'timeFrame': 'From day 0 to day 7', 'description': 'A significant hypoxemia is an arterial partial pressure of oxygen of less than 60 mmHg despite an oxygen flow of more than 6 L/min, patient at rest.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sars-CoV-2, Community-Acquired Pneumonia,COVID-19']}, 'descriptionModule': {'briefSummary': 'Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Positive Sars-CoV-2 RT-PCR on nasopharyngeal swab\n* CT scan suggestive of Sars-CoV-2 pneumonia\n\nExclusion Criteria:\n\n* Negative Sars-CoV-2 RT-PCR on nasopharyngeal swab\n* Known hypersensitivity to Hydroxychloroquine, Azithromycin or a macrolide family member\n* Long term prescribed treatment contraindicated with azithromycin (colchicine, ergotamine, dihydroergotamine) and/or hydroxychloroquine (citalopram, escitalopram, hydroxyzine, domperidone, piperaquin)\n* Retinopathy or maculopathy\n* Porphyria\n* Severe renal failure (GFR less than 30 mL/min/m²)\n* Dyskaliemia, (ie less than 3,5 mmol/L or more than 5,5 mmol/L)\n* Hypomagnesiemia, ie less than 0,7 mmol/L\n* Severe cholestasis, cirrhosis or severe hepatic failure\n* Known cardiac medical history of congestive heart failure or myocardial infarction\n* Bradycardia less than 50 beats per minute\n* Prolonged corrected QT interval, (ie cQT more than 440 ms in men and 450 ms in women) or medical history of ventricular cardiac rhythm disorders\n* Blood disorders with history of hematopoietic stem cells allograft\n* Known history of G6PD deficiency\n* Pregnancy\n* Breastfeeding\n* Subject protected by law under guardianship of curatorship\n* Inability to take oral medications'}, 'identificationModule': {'nctId': 'NCT04347512', 'acronym': 'TEACHCOVID', 'briefTitle': 'EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA', 'orgStudyIdInfo': {'id': '7783'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5).\n\nStandard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc)', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The patient is given antibiotics only. Standard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc).', 'interventionNames': ['Drug: Control arm']}, {'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine and Azithromycin', 'description': 'Hydroxychloroquine is given for 5 days, with a loading dose of 400 mg qd at D1, and 200 mg qd for the next 4 days (D2-D5).\n\nAzithromycin is given for 5 days, with a loading dose of 500 mg at D1, and 250 mg for the next 4 days.\n\nStandard of care is also prescribed (oxygen therapy, analgesics, antipyretics, anticoagulant drug, etc) In case of moderate renal failure (glomerular filtration rate between 30 and 60 mL/min/m²), hydroxychloroquine dosage are lowered by half.', 'interventionNames': ['Drug: Hydroxychloroquine and azithromycin treatment arm.']}], 'interventions': [{'name': 'Hydroxychloroquine and azithromycin treatment arm.', 'type': 'DRUG', 'description': 'Patient allocated in this arm receive hydroxychloroquine and azithromycin for 5 days.\n\nFor hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.\n\nFor azithromycin, there is a loading dose of 500 mg per day at D1, followed by 250 mg per day D2-D5.\n\nEvery patient receive as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).', 'armGroupLabels': ['Hydroxychloroquine and Azithromycin']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Patient allocated in this arm receive hydroxychloroquine for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.\n\nEvery patient receives as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Control arm', 'type': 'DRUG', 'description': 'In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}