Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT04645433
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2020-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-11-07', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality for ICU', 'timeFrame': '14 days', 'description': 'If the patient dies, we have reached an outcome'}, {'measure': 'hospital stay', 'timeFrame': '14 days', 'description': 'If the hospital stay exceeds 14 days, we have reached an outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid 19', 'favipiravir'], 'conditions': ['Mortality', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience', 'detailedDescription': 'Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to intensive care units (ICU) between March o 10thand May 10th 2020 due to COVID-19 infection were included to the study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years and older\n\nExclusion Criteria:\n\n* patients younger than 18 years old\n* patients who have received both lopinavir-ritonavir and favipiravir sepuentially'}, 'identificationModule': {'nctId': 'NCT04645433', 'briefTitle': 'Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit: Single Center Experience', 'orgStudyIdInfo': {'id': '2854'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Favipiravir therapy', 'description': 'Favipiravir was advised to all patients with severe pneumonia and progressing pneumonia findings or worsening clinical manifestations except pregnant, breast feeding, postpartum woman. PCR results were not waited to start favipiravir in this group of patients and continued if it would be negative but tomography findings were consistent with COVID-19. Loading dose was 1600 mg twice a day. Maintenance dose was 600 mg per 12 hours for four days.'}, {'label': 'Lopinavir-ritonavir therapy', 'description': 'Lopinavir-ritonavir therapy was used in selected ICU patients before widespread availability of favipiravir (23 March 2020) and/or if favipiravir was contraindicated. Combination of lopinavir 200 mg-ritonavir 50 mg tablet was the given form. It was given as double tablets twice daily for 10-14 days. Patients were accepted as under favipiravir therapy if they had incomplete course of lopinavir-ritonavir therapy (less than 5 days) and followed by favipiravir for 5 days.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34771', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'SisliHamidiye Etfal Education and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'sultan acar sevinc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sisli Hamidiye Etfal Education and Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Sultan Acar Sevinç', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}