Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 11:42 PM
Study NCT ID:
NCT05252468
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2022-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 693}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2022-02-10', 'studyFirstSubmitQcDate': '2022-02-22', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate the efficacy of Taffix in preventing upper respiratory infection', 'timeFrame': 'Through study completion, 6 weeks', 'description': 'Incidence of symptoms (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat), as reported in Bi-weekly questionnaires, at subjects who were negative to SARS-CoV-2'}, {'measure': 'Severity of COVID-19', 'timeFrame': 'Through study completion, 6 weeks', 'description': 'Severity of COVID-19 cases (according to NIH severity categories)'}, {'measure': 'Change in Allergic Rhinitis or Asthma symptoms in relevant subjects', 'timeFrame': 'Through study completion, 6 weeks', 'description': 'By report to the study coordinator, among subjects who reported of that condition at the entry to the study.'}], 'primaryOutcomes': [{'measure': 'COVID-19 new cases', 'timeFrame': 'Through study completion, 6 weeks', 'description': 'symptoms score (Fever; Cough; Rigors; Myalgia; Headache; Vomiting or Diarrhea; Shortness of breath; Breathing difficulties; New olfactory and taste disorder(s); Runny or stuffy nose; Sore throat) as reported in Bi-weekly questionnaires, PCR or antigen test at symptomatic subjects, serology test at end of the study.'}], 'secondaryOutcomes': [{'measure': 'The safety and tolerability of the study device.', 'timeFrame': 'Through study completion, 6 weeks.', 'description': 'Incidence of adverse events as reported by subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upper respiratory tract infection', 'viruses', 'COVID-19', 'nasal', 'powder', 'prevention', 'SARS-CoV-2'], 'conditions': ['COVID-19', 'Upper Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'TAFFIX is a nasal powder spray that immediately creates a protective acidic barrier on the nasal mucosa against infection by inhaled viruses. The protective barrier lasts 5 hours.\n\nTAFFIX is approved as a medical device in Israel, intended for use to block inhaled viruses within the nasal cavity. In Europe, it is registered as a medical device indicated for use as a protective mechanical barrier against allergens and viruses (e.g., SARS-CoV-2) within the nasal cavity.\n\nTAFFIX is used as additional safety mean together with masks, hygiene, and social distancing.\n\nThe study rationale is to evaluate whether daily use of TaffiX™ as prophylaxis will reduce the rate of SARS- CoV-2 infection and other upper respiratory infections, compared to the placebo control rate.', 'detailedDescription': 'Study Design:\n\nThis is a 2 arms, Randomized, double blind, placebo controlled clinical trial.\n\nStudy population:\n\nSubjects who, were not diagnosed with COVID-19 previously to their best knowledge and according to COVID-19 antibody test.\n\nWere not vaccinated yet against COVID-19 and will not be vaccinated during their participating in the study.\n\nUp to 1000(500 per study arm) will be enrolled for the purpose of this study.\n\nStudy treatment:\n\nTaffiX™ will be used daily (up to 3 times a day, every 5 hours) in addition to the protective measures instructed by the Ministry of Health The control group will be administrated with Placebo- lactose powder for nasal application\n\nParticipation duration:\n\nUp to 6 weeks\n\nConcomitant therpay:\n\nAllowed- no restriction for Concomitant Medications\n\nPlanned interim analyses:\n\nWhen no less than 150 subjects have completed the study, an interim analysis for Efficacy and safety will be conducted by an independent biostatistician.\n\nAfter no less than 500 subjects, additional interim analysis for Efficacy and safety will be conducted by an independent biostatistician.\n\nSerious adverse events will be monitored by an independent safety officer on an ongoing basis throughout the study.\n\nStop Rule:\n\nIf the proportion of COVID-19 positive rate in the treatment group is statistically significantly lower than the proportion of COVID-19 positive rate in the placebo control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects 12 yr and older who had not previously been infected with COVID-19 to the best of their knowledge.\n2. Were not vaccinated yet against COVID-19 and will not be vaccinated during the study (if they decide to get the vaccine during the study they will be excluded a week later).\n3. Negative serology rapid test to COVID-19.\n4. Be informed of the nature of the study and the procedures and sign an informed consent form.\n5. Willing and able to adhere to Protocol requirements.\n6. If female of childbearing potential, agree to use an acceptable method of birth control or be surgically sterile, and have a negative pregnancy test.\n\nExclusion Criteria:\n\n1. Known sensitivity to citric acid and/or sodium citrate and /or benzalkonium chloride and /or Hydroxypropylmethylcellulose (HPMC) or lactose (does not mean diagnosed lactose intolerance in food).\n2. Females who are pregnant or are lactating as reported by the subject.'}, 'identificationModule': {'nctId': 'NCT05252468', 'briefTitle': 'COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nasus Pharma'}, 'officialTitle': 'COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19).', 'orgStudyIdInfo': {'id': 'NP-003-Taffix'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TaffiX™', 'description': 'TaffiX™ is a Nasal powder personal spray that blocks viruses particles from entering the nasal cells.', 'interventionNames': ['Device: TaffiX™']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lactose powder', 'description': 'Lactose nasal powder will be used as a placebo. It has an identical appearance as TaffiX™ (white powder in an identical bottle).', 'interventionNames': ['Device: TaffiX™']}], 'interventions': [{'name': 'TaffiX™', 'type': 'DEVICE', 'description': 'Personal nasal powder spray.', 'armGroupLabels': ['Lactose powder', 'TaffiX™']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Diagnostics and Consultation Center Convex Ltd', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Emil Kolev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nasus Pharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nasus Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}