Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04436458
Status:
WITHDRAWN
Last Update Posted:
2022-02-21
First Post:
2020-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Niclosamide In Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009534', 'term': 'Niclosamide'}], '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor asset acquired by another pharma company who opened their own IND for this compound. First Wave Bio never started this study in the US or ex-US.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-04', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is the rate of faecal SARS-CoV-2 virus clearance (rectal swab or stool sample) assessed by RT-PCR in the niclosamide group, compared to the placebo group', 'timeFrame': 'From Day 1 to 42'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multicentre, randomized, double blind, 2 arm placebo-controlled study in adults with moderate COVID-19 with gastrointestinal signs and symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients hospitalized for treatment of COVID-19 with or without pneumonia, who are expected to remain in hospital at least seven days after the randomization and who accept continuing to be assessed for the study procedures (home or outpatient unit) up to 6 weeks in case of discharge.\n* Patients who prior to developing COVID-19 usually have normal bowel habits defined as at least 3 stools per week and no more than 3 stools per day.\n* SARS-CoV-2 infection confirmed by RT-PCR in rectal swab (or stool test) ≤2 days before randomization by local or central lab.\n* Diarrhea defined as at least 3 watery stools in the last 24 hours prior to enrolment\n\nExclusion Criteria:\n\n* At the time of randomization patients requiring ICU admission or patients with severe respiratory insufficiency requiring mechanical ventilation or with rapid worsening of respiratory function leading to expectation for mechanical ventilation or ICU admission.\n* Evidence of rapid clinical deterioration or existence of any life-threatening co-morbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT04436458', 'briefTitle': 'Niclosamide In Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entero Therapeutics'}, 'officialTitle': 'Phase 2, Multicentre, Randomized, Double Blind, 2 Arms Placebo-controlled Study in Adults With Moderate COVID-19 With Gastrointestinal Signs and Symptoms', 'orgStudyIdInfo': {'id': 'FW-COV-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niclosamide', 'description': 'Continued SOC therapy together with Niclosamide tablets for 14 days', 'interventionNames': ['Drug: Niclosamide Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Continued SOC therapy together with placebo tablets matching niclosamide', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Niclosamide Oral Tablet', 'type': 'DRUG', 'description': 'Continued SOC therapy together with niclosamide TID for 14 days', 'armGroupLabels': ['Niclosamide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Continued SOC therapy together with placebo tablets matching niclosamide for 14 days', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entero Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}