Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-30 @ 8:54 AM
Study NCT ID:
NCT04361461
Status:
WITHDRAWN
Last Update Posted:
2020-11-19
First Post:
2020-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}], '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': '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was canceled before enrollment due to a decision by the Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-18', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of serious adverse events', 'timeFrame': 'Day 14th', 'description': 'Rates of serious adverse events'}], 'primaryOutcomes': [{'measure': 'Individual response rate', 'timeFrame': '14 days after randomization', 'description': 'The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '28 days after randomization', 'description': 'All-cause mortality rates at Day 28th after randomization'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'baseline', 'description': 'Number of days that the patient was on mechanical ventilation which was under ventilation from basal line'}, {'measure': 'Proportion of patients which needed mechanical ventilation during study', 'timeFrame': 'hospitalization within 28 days', 'description': 'Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.'}, {'measure': 'World Health Organization (WHO) Ordinal scale', 'timeFrame': '28 days after inclusion and compared to baseline', 'description': 'The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.'}, {'measure': 'Duration of hospitalization', 'timeFrame': 'hospitalization within 28 days', 'description': 'Length of hospital stay in days for hospitalization'}, {'measure': 'Rates of drug discontinuation', 'timeFrame': 'hospitalization within 28 days', 'description': 'Rates of drug discontinuation in all causes under study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Infections', 'SARS-CoV 2', 'SARS (Severe Acute Respiratory Syndrome)', 'Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged \\> 18 years;\n* Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea);\n* Diagnosis confirmed by real-time PCR or suspected COVID-19;\n* Hospitalized patients with:\n* Moderate disease: hypoxemia with O2 saturation \\<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%;\n\nor\n\n* Serious illness: Hospitalized patients with hypoxemia with O2 saturation \\<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation.\n\nExclusion Criteria:\n\n* Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia;\n* Liver failure or elevation of transaminases greater than 5 times;\n* Cardiac patients with electrocardiogram with extended QT interval;\n* Pregnant women;\n* Use in the last 30 days of hydroxychloroquine or azithromycin;\n* Allergy to hydroxychloroquine or azithromycin.'}, 'identificationModule': {'nctId': 'NCT04361461', 'briefTitle': 'Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Apsen Farmaceutica S.A.'}, 'officialTitle': 'Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)', 'orgStudyIdInfo': {'id': 'APS000/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Hydroxychloroquine (400 mg)', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Hydroxychloroquine (400 mg) + azithromycin (500 mg)', 'interventionNames': ['Drug: Hydroxychloroquine Sulfate + Azythromycin']}], 'interventions': [{'name': 'Hydroxychloroquine Sulfate', 'type': 'DRUG', 'otherNames': ['Reuquinol®'], 'description': '400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.', 'armGroupLabels': ['Group 1']}, {'name': 'Hydroxychloroquine Sulfate + Azythromycin', 'type': 'DRUG', 'otherNames': ['Reuquinol® + Azythromycin'], 'description': '400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days.', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04753-001', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Apsen Farmacêutica S.A.', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apsen Farmaceutica S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Federal University of São Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}