Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT04750759
Status:
TERMINATED
Last Update Posted:
2021-12-09
First Post:
2021-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
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': 'D009534', 'term': 'Niclosamide'}, {'id': 'C034532', 'term': 'camostat'}], 'ancestors': [{'id': 'D012458', 'term': 'Salicylanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'sub-therapeutic plasma levels of active substance', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-26', 'studyFirstSubmitDate': '2021-02-08', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment emergent number of Adverse Events', 'timeFrame': '21 days', 'description': 'All pathological and clinically significant findings in physical examinations, vital signs, 12-lead ECGs, oxygen saturation and safety lab including coagulation will be documented as adverse events. Adverse events will be reported on the basis of CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Niclosamide (2000 mg QD) and Camostate (600 mg QID) are expected to be safe and well-tolerated as a combination therapy and to show clinically beneficial for COVID-19 patients.', 'detailedDescription': 'Niclosamide is an approved drug for the treatment of intestinal worm infections that can potentially induce the process of autophagy and thus significantly limit viral replication in cells.\n\nCamostat is approved in Japan for the treatment of chronic pancreatitis and reflux esophagitis. It has been shown to effectively block viral replication in a SARS-CoV-2 animal model.\n\nSince the mechanisms of actions are different, it was hypothesized that a combination of both substances might have an additive or even synergistic effect in the treatment of patients with COVID-19.\n\nThis study is designed to investigate the safety, tolerability and preliminary efficacy of the treatment combination niclosamide and camostat in mild and moderately affected COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients in the age of 18 to 70 years\n* Having a recent positive direct test for Sars-CoV-2\n* Having mild or moderate COVID-19 symptoms with no indication for hospitalization due to SARS-CoV-2 infection (WHO Ordinal Scale 1-2)\n\nExclusion Criteria:\n\n* Severe respiratory symptoms related to COVID-19 requiring oxygen or intensive care (high flow oxygen or mechanical ventilation or ECMO)\n* Patients with preexisting pulmonary diseases requiring oxygen supply\n* Patients with history of hypersensitivity to Camostat or Niclosamide or to any ingredients to any of the two drugs\n* Patients with heart failure (NYHA III or NYHA IV)\n* Patients with proven malignant tumor\n* Patients diagnosed with influenza infection\n* Pregnancy or breastfeeding\n* Immunocompromised patients\n* Creatinine clearance \\< 60 mL/min\n* aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \\> 2 times upper limit of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT04750759', 'acronym': 'NICCAM', 'briefTitle': 'Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat', 'organization': {'class': 'OTHER', 'fullName': 'Charité Research Organisation GmbH'}, 'officialTitle': 'A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 ("NICCAM")', 'orgStudyIdInfo': {'id': '201741'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Niclosamide + Camostat', 'description': 'Patients will receive the combination of niclosamide chewing tablets (2000 mg, once daily) and camostat tablets (600 mg, 4-times daily) over a period of 7 days.', 'interventionNames': ['Drug: Niclosamide + Camostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will receive placebo orally over a period of 7 days.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Niclosamide + Camostat', 'type': 'DRUG', 'otherNames': ['Yomesan', 'Foipan'], 'description': 'Niclosamide will be applied in combination with camostat.', 'armGroupLabels': ['Niclosamide + Camostat']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo to interventional drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research Organisation GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Martin Witzenrath, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charité Research Organisation GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}