Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:55 AM
Study NCT ID:
NCT07308158
Status:
COMPLETED
Last Update Posted:
2026-01-08
First Post:
2025-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Covid Flu A/B and RSV 4 in 1 Diagnostic Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-07', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of the Investigational Test for Detection of Influenza A, Influenza B, SARS-CoV-2 and Respiratory Syncytial Virus Compared to an FDA-Cleared Reference Method', 'timeFrame': 'Within approximately 5 days of specimen collection (time needed for both investigational and comparator test results)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Influenza A', 'Influenza B', 'COVID - 19', 'RSV']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.\n\nThe main questions it aims to answer are:\n\n1. What is the sensitivity and specificity of the investigational test compared with an FDA-cleared reference method for detection of Influenza A, Influenza B, , SARS-CoV-2 and respiratory syncytial virus antigen.\n2. What is the overall positive and negative percent agreement between the investigational test and the reference method?\n\nParticipants will:\n\n1. Provide a respiratory specimen (e.g., nasal or nasopharyngeal swab) for testing with the investigational device.\n2. Provide an additional specimen for testing with the FDA-cleared reference method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with flu-like symptoms presenting to participating clinical sites', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent obtained prior to study enrollment.\n* Male or female aged six (6) months or older.\n* Subject is currently exhibiting two or more symptoms associated with COVID-19, influenza or RSV (such as, but not limited to, fever, chills, cough, shortness of breath or difficulty breathing, fatigue, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting or diarrhea and must present within six (6) days of symptom onset). Subject must still be exhibiting symptoms on the day of sample collection.\n\nExclusion Criteria:\n\n* Subject who is 18 years of age (or the state's legal age of majority) or older and does not understand or is not able and willing to sign the study informed consent.\n* Subject has had seasonal influenza and/or the SARS-CoV-2 and/or the RSV vaccine within the past 5 days.\n* Subject is not able to tolerate sample collection, or is not willing to contribute the required swab samples for testing or complete the study procedures.\n* Subject is currently undergoing antiviral treatment such as baloxavir marboxil (trade name Xofluza®), oseltamivir (Tamiflu®), zanamivir (Relenza®), or peramivir (Rapivab®).\n* Subjects currently undergoing treatment and/or within the past thirty (30) days with prescription medication to treat novel Coronavirus SARS-CoV-2 infection, which may include but is not limited to Remdesivir (Veklury), Paxlovid, molnupiravir or receiving convalescent plasma therapy for SARS-CoV-2.\n* Subjects who have taken Evusheld (tixagevimab/cilgavimab) within the last 90 days.\n* Subjects who have had a nasal wash or aspirate as part of their standard of care treatment on day of study visit prior to the study sample collection.\n* Subjects who have had recent craniofacial injury or surgery, including to correct deviation of the nasal septum, within the previous six (6) months."}, 'identificationModule': {'nctId': 'NCT07308158', 'briefTitle': 'Covid Flu A/B and RSV 4 in 1 Diagnostic Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'iHealth Labs inc'}, 'officialTitle': 'Human Factors and Clinical Validation of the iHealth Labs Inc iHealth Flu A&B/COVID-19/RSV Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use', 'orgStudyIdInfo': {'id': 'iH018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Investigational Flu A/B Covid-19 and RSV Diagnostic Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A diagnostic test in lateral flow cassette format designed to detect Influenza A, Influenza B, SARS-CoV-2 and respiratory syncytial virus from anterior nasal swab specimens.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'iHealth Site 006', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35173', 'city': 'Trussville', 'state': 'Alabama', 'country': 'United States', 'facility': 'iHealth Site 021', 'geoPoint': {'lat': 33.61983, 'lon': -86.60888}}, {'zip': '94568', 'city': 'Dublin', 'state': 'California', 'country': 'United States', 'facility': 'iHealth Site 017', 'geoPoint': {'lat': 37.70215, 'lon': -121.93579}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'iHealth Site 007', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '91602', 'city': 'Toluca Lake', 'state': 'California', 'country': 'United States', 'facility': 'iHealth Site 026', 'geoPoint': {'lat': 34.15206, 'lon': -118.35719}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 011', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 013', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 004', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 005', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33461', 'city': 'Palm Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 019', 'geoPoint': {'lat': 26.6359, 'lon': -80.09615}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'facility': 'iHealth Site 014', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '83406', 'city': 'Ammon', 'state': 'Idaho', 'country': 'United States', 'facility': 'iHealth Site 009', 'geoPoint': {'lat': 43.46964, 'lon': -111.96664}}, {'zip': '08820', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'iHealth Site 027', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '29681', 'city': 'Simpsonville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'iHealth Site 015', 'geoPoint': {'lat': 34.73706, 'lon': -82.25428}}, {'zip': '29301', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'iHealth Site 016', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '37412', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'iHealth Site 020', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78520', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'iHealth Site 003', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'country': 'United States', 'facility': 'iHealth Site 002', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'iHealth Site 018', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '75149', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'iHealth Site 023', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'iHealth Site 025', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '00678', 'city': 'Quebradillas', 'country': 'Puerto Rico', 'facility': 'iHealth Site 001', 'geoPoint': {'lat': 18.47383, 'lon': -66.93851}}, {'zip': '000927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'iHealth Site 022', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iHealth Labs inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}