Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04341493
Status:
TERMINATED
Last Update Posted:
2021-04-01
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients won´t know whether the treatment they receive is hydroxychloroquine or nitazoxanide + hydroxychloroquine.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this study all patients with a COVID-19 positive result attended at the Health Institute of the State of Mexico (ISEM), will be invited to participate and offered one of two options that try to reduce the complications of this disease.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Concerns about safety of Hydroxychloroquine', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical ventilation requirement', 'timeFrame': 'Since the diagnosis until two weeks after', 'description': 'Percentage of patients COVID-19 positive that required mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment', 'Evolution'], 'conditions': ['Coronavirus Infection']}, 'referencesModule': {'references': [{'pmid': '27095301', 'type': 'BACKGROUND', 'citation': 'Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.'}, {'pmid': '27585965', 'type': 'BACKGROUND', 'citation': 'Mo Y, Fisher D. A review of treatment modalities for Middle East Respiratory Syndrome. J Antimicrob Chemother. 2016 Dec;71(12):3340-3350. doi: 10.1093/jac/dkw338. Epub 2016 Sep 1.'}, {'pmid': '32164080', 'type': 'BACKGROUND', 'citation': 'Li H, Wang YM, Xu JY, Cao B. [Potential antiviral therapeutics for 2019 Novel Coronavirus]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):170-172. doi: 10.3760/cma.j.issn.1001-0939.2020.03.004. Chinese.'}, {'pmid': '32513231', 'type': 'DERIVED', 'citation': 'Calderon JM, Zeron HM, Padmanabhan S. Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):504. doi: 10.1186/s13063-020-04448-2.'}]}, 'descriptionModule': {'briefSummary': 'Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.', 'detailedDescription': "Introduction The current pandemic caused by the SARS-COV2 coronavirus (COVID-19) is life-threatening and is challenging the world's best health systems. Accelerated spread of this pandemia led physicians to try a variety of treatments without a well established sequence due to ignorance about this new disease. The case fatality rate has been calculated at 2.2% but there are differences depending on the country affected.\n\nPerspective When comparing the evolution of cases between Spain and Mexico, an apparently less pronounced trend is observed in Mexico, but this may be due to underdiagnosis. In calculations by the Mexican Ministry of Health, around 6% of the patients (approximately 10,500) who contract COVID-19 could be found serious and in need of hospitalization in intensive care.\n\nNTZx NTZx and its circulating active metabolite, tizoxanide, inhibit the replication of a wide range of viruses, both RNA and DNA. It has action against 16 strains of Influenza A virus subtypes H1N1, H3N2, H3N2v, H3N8, H5N9, H7N1 and a strain of influenza B. It also works against respiratory syncytial virus, norovirus, dengue, yellow fever, Japanese encephalitis virus, rotavirus , hepatitis B and C, even against the human immunodeficiency virus (Severe Acute Respiratory Syndrome (SARS) and Middle East respiratory syndrome (MERS).\n\nProblem Mexico is in Phase 2 according to the World Health Organization (WHO) and more local infections due to coronaviruses are expected. To date, various COVID-19 treatment schemes are being tested, but the usefulness of none can be assured.\n\nWhen reviewing the drug schemes that are being carried out in the world, it calls the attention that developing countries are not included, beyond the fact that the tested alternatives are economically inaccessible.\n\nThis clinical survey aims to test the possible utility of NTZx against COVID-19, alone or in combination with hydroxychloroquine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 positive patients\n* Treated at the Health Institute of the State of Mexico (ISEM).\n* With risk factors to get complicated: age more than 60 years old, diabetes mellitus or obesity grade II or more.\n\nExclusion Criteria:\n\n* Patients who have inherent contraindications to each drug.'}, 'identificationModule': {'nctId': 'NCT04341493', 'briefTitle': 'Hydroxychloroquine vs Nitazoxanide in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Materno-Perinatal Hospital of the State of Mexico'}, 'officialTitle': 'Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome', 'orgStudyIdInfo': {'id': '2020-03-681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitazoxanide + hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg PO every 12 hours for two days and then 200 mg PO every 12 hours for four days + Nitazoxanide 500 mg PO every 6 hours for six days', 'interventionNames': ['Drug: Nitazoxanide 500 MG', 'Drug: Hydroxychloroquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 200 mg PO every 12 hours for 7 days', 'interventionNames': ['Drug: Hydroxychloroquine']}], 'interventions': [{'name': 'Nitazoxanide 500 MG', 'type': 'DRUG', 'otherNames': ['hydroxychloroquine'], 'description': 'Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs', 'armGroupLabels': ['Nitazoxanide + hydroxychloroquine']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with one drug', 'armGroupLabels': ['Hydroxychloroquine', 'Nitazoxanide + hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50130', 'city': 'Toluca', 'country': 'Mexico', 'facility': 'Materno-Perinatal Hospital "Mónica Pretelini"', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}], 'overallOfficials': [{'name': 'José Meneses Calderón, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Materno-Perinatal "Mónica Pretelini Sáenz"'}, {'name': 'Srivatsan Padmanabhan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Joseph Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After finishing the study.', 'ipdSharing': 'YES', 'description': 'If the final selected medical journal to send the paper of our research request it, we will add the full database of the studied population.', 'accessCriteria': 'Requested by the journal or after publication if any researcher in the world express interest if the information of this survey.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugo Mendieta Zeron', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of the Research Department', 'investigatorFullName': 'Hugo Mendieta Zeron', 'investigatorAffiliation': 'Materno-Perinatal Hospital of the State of Mexico'}}}}