Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 2:10 PM
Study NCT ID:
NCT01146535
Status:
COMPLETED
Last Update Posted:
2013-08-21
First Post:
2010-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D053139', 'term': 'Oseltamivir'}, {'id': 'D008320', 'term': 'Maltose'}], 'ancestors': [{'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2010-06-16', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2013-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of fever and flu symptoms', 'timeFrame': 'Days 1-5', 'description': 'Time to resolution of influenza symptoms defined as all flu symptoms scored as \\<=1 and change in viral load (RT-PCR).'}], 'secondaryOutcomes': [{'measure': 'Clinical response', 'timeFrame': 'Day 3 and Day 6', 'description': 'Proportion of clinical responders on Day 3 and Day 6: defined as no fever (oral temperature \\< 38 °C and no subjective fever) AND resolution of influenza illness (all flu symptoms and interference scored as ≤ 1).'}, {'measure': 'Proportion of poor responders', 'timeFrame': 'Day 3 and Day 6', 'description': 'Proportion of poor responders on both Day 3 and Day 6: defined as subjects with fever (oral temperature ≥ 38 °C or any record of subjective fever) OR unresolved influenza illness (1 or more flu symptoms/interferences scored as \\> 1).'}, {'measure': 'Time to resolution of fever', 'timeFrame': 'Days 1-5', 'description': 'Time to bring down a fever (oral temperature \\< 38 °C and no subjective fever) and time to return to afebrile state (oral temperature ≤ 37.2 °C and no subjective fever).'}, {'measure': 'Time to resolution of influenza illness', 'timeFrame': 'Days 1-5', 'description': 'Time to resolution of influenza illness (all flu symptoms and interference scored as ≤ 1) as reported by the subject.'}, {'measure': 'Symptom improvement', 'timeFrame': 'Days 1-5', 'description': 'Improvement of influenza symptoms and level of interference of disease during treatment period as reported by the subject.'}, {'measure': 'OTC medication usage', 'timeFrame': 'Days 1-5', 'description': 'Proportion of use of the OTC medication for fever or influenza symptoms.'}, {'measure': 'Physician visits', 'timeFrame': 'Days 6-10', 'description': 'Rate of requirement for additional physician visits within 5 days treatment period.'}, {'measure': 'Treatment failure', 'timeFrame': 'Days 1-28', 'description': 'Rate of treatment failure including hospitalization due to disease progression prior to Day 29.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['interferon-alpha', 'oseltamivir', 'drug therapy, combination', 'influenza', 'therapies, investigational'], 'conditions': ['Influenza A Virus Infection']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and effect of interferon-alpha lozenges when used in combination with oseltamivir (Tamiflu) to treat influenza.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* fever \\>=38C\n* one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of \\< 48 hours' duration\n* body weight \\> 40 kg\n* positive for influenza A (nasal swab rapid test)\n\nExclusion Criteria:\n\n* pregnancy/lactation\n* history of depression or psychiatric disorders\n* history of conditions that could complicate flu infection, such as chronic pulmonary, cardiac, renal, or metabolic disorders\n* use of immunosuppressive therapy\n* HIV infection"}, 'identificationModule': {'nctId': 'NCT01146535', 'briefTitle': 'Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ainos, Inc. (f/k/a Amarillo Biosciences Inc.'}, 'officialTitle': 'Pilot Study of Interferon Alpha Lozenges Plus Oseltamivir in the Treatment of Influenza A Infection', 'orgStudyIdInfo': {'id': 'QCR09025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interferon-alpha', 'description': 'Interferon-alpha\n\n150 IU lozenges bid for 5 days', 'interventionNames': ['Drug: Interferon-alpha', 'Drug: Oseltamivir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'maltose', 'description': 'maltose\n\n200 mg maltose lozenges bid for 5 days', 'interventionNames': ['Drug: Oseltamivir', 'Other: maltose']}], 'interventions': [{'name': 'Interferon-alpha', 'type': 'DRUG', 'otherNames': ['IFN lozenge'], 'description': '150 IU lozenges bid for 5 days', 'armGroupLabels': ['Interferon-alpha']}, {'name': 'Oseltamivir', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': '75 mg capsules bid for 5 days', 'armGroupLabels': ['Interferon-alpha', 'maltose']}, {'name': 'maltose', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': '200 mg maltose lozenges bid for 5 days', 'armGroupLabels': ['maltose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Guishan', 'state': 'Taoyuan County', 'country': 'Taiwan', 'facility': 'Chang Gung Medical Foundation, LinKou Branch', 'geoPoint': {'lat': 24.99436, 'lon': 121.33672}}, {'zip': '81362', 'city': 'Kaohsiung City', 'state': 'Zuoying District', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '800', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Show-Chwan Memorial Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Taiwan Municipal Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ainos, Inc. (f/k/a Amarillo Biosciences Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CytoPharm, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}