[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587418":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":20,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":20,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":35,"maxAge":20,"enrollmentInfo":36,"targetDuration":20,"studyType":39,"phases":40,"briefSummary":42,"conditions":43,"keywords":20,"overallStatus":47,"whyStopped":20,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":20},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Experimental: Nasal sampling\u002FTesting (Self-Test)","EXPERIMENTAL","Each Participant will be provided a single-use test kit containing a BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, buffer and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, then interpret and record the result. The testing will be completed in a home like setting. After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2.\n\nThe order of collections will be based off the subject number.",[13],"Diagnostic Test: BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test","Diagnostic Test: BinaxNOW™ COVID-19\u002FFlu A\\&B Combo Self-Test\n\nThe BinaxNOW™ COVID-19\u002FFlu A\\&B Combo Self-Test is a visually read lateral flow in vitro immunoassay for the qualitative detection and differentiation of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Samantha Parsons, Manager of Clinical Operations","CONTACT","000-000-0000","samantha.parsons@abbott.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100587418",false,"NCT06928129","Clinical Feasibility of the BinaxNOW™ COVID-19\u002FFlu A&B Combo in the Southern Hemisphere","Inclusion Criteria:\n\n* Participant is at least two (2) years of age, AND Participant is suspected of acute viral respiratory infection by a healthcare professional, AND\n* Participant is within five (5) days of symptom onset, AND\n\nParticipant is experiencing two or more of the following symptoms:\n\nFever of \\>100.0°F\u002F 37.8°C or chills, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache\n\n-The Participant and\u002For legally authorized representative is willing to undergo the informed consent\u002FAssent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.\n\nExclusion Criteria:\n\n* Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment\n* Participants with an active nosebleed\n* Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment\n* Participant has tested positive for COVID-19 within the last 45 days\n* Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.\n* Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days.\n* Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals (such as Paxlovid), convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)\n* Participant is unable to meet all inclusion criteria as listed above","ALL","2 Years",{"count":37,"type":38},700,"ESTIMATED","INTERVENTIONAL",[41],"NA","The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient\u002Flay user.",[44,45,46],"Influenza Type A","Influenza Type B","COVID-19","NOT_YET_RECRUITING","2025-04-10",{"date":50,"type":51},"2025-04-15","ACTUAL",{"date":53,"type":38},"2025-06-30",{"date":55,"type":38},"2025-11-01",{"name":5,"class":6}]