Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT04423861
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2020-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of mechanical ventilation', 'timeFrame': '14 days', 'description': 'Evaluation of change in acute respiratory syndrome using WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)'}], 'secondaryOutcomes': [{'measure': 'Change in the pulmonary condition', 'timeFrame': 'Baseline, Day 7 and Day 14', 'description': 'Evaluation of change in oximetry, respiratory rate and need for oxygen therapy'}, {'measure': 'Change in Clinical Condition', 'timeFrame': 'Baseline, Day 7 and Day 14', 'description': 'Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction'}, {'measure': 'Change in tomographic pulmonary condition', 'timeFrame': 'Baseline, Day 7', 'description': 'Evaluation of change in chest CT'}, {'measure': 'Rate of mortality within 14-days', 'timeFrame': '14 days', 'description': 'Evaluation of change in acute respiratory syndrome'}, {'measure': 'Change in inflammatory markers', 'timeFrame': 'Baseine, Day 7, Day 14', 'description': 'Evaluation of change in inflammatory markers d-dimer and IL-6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['covid19']}, 'descriptionModule': {'briefSummary': 'This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.', 'detailedDescription': 'This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.\n\nThe aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..\n\nTherefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent from patient or legal representative.\n2. Male or female, aged ≥ 18 years;\n3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase\n4. chain reaction (RT-PCR) from any diagnostic sampling source;\n5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation \\<98%;\n\n7\\. Negative result for pregnancy test (if applicable).\n\nExclusion Criteria:\n\n1. Participating in another RCT in the past 12 months;\n2. Known allergy to nitazoxanide\n3. Severely reduced LV function;\n4. Severely reduced renal function;\n5. Pregnancy or breast feeding;\n6. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);\n7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;\n8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy;\n9. Diagnose of severe autoimmune diseases in immunosuppression;\n10. Transplanted patients;\n11. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products'}, 'identificationModule': {'nctId': 'NCT04423861', 'briefTitle': 'Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': 'A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition', 'orgStudyIdInfo': {'id': 'NITFQM0920OR-III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nitazoxanide BID', 'description': 'Patients will receive nitazoxanide 600 mg BID for 7 days.', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive matching placebo BID for 7 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['Viranitta (Nitazoxanide)'], 'description': 'Patients will receive nitazoxanide 600 mg BID for 7 days.', 'armGroupLabels': ['nitazoxanide BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive matching placebo BID for 7 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Campinas', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Florentino de Araujo Cardoso Filho, MD, PhD', 'role': 'CONTACT', 'email': 'florentino.cardoso@hospitalcare.com.br', 'phone': '+55 19 991232882'}, {'name': 'Luciana Ferrara', 'role': 'CONTACT', 'email': 'luciana.ferrara@azidusbrasil.com.br', 'phone': '+55 19 981428814'}], 'facility': 'Hospital Vera Cruz', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'centralContacts': [{'name': 'Florentino de Araujo Cardoso Filho, MD, PhD', 'role': 'CONTACT', 'email': 'florentino.cardoso@hospitalcare.com.br', 'phone': '+55 19 991232882'}, {'name': 'Luciana Ferrara', 'role': 'CONTACT', 'email': 'luciana.ferrara@azidusbrasil.com.br', 'phone': '+55 19 981428814'}], 'overallOfficials': [{'name': 'Florentino de Araujo Cardoso Filho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '+55 19 991232882'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Farmoquimica S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}