[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609939":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":34,"responsibleParty":130,"collaborators":132,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":10,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":10,"maxAge":10,"enrollmentInfo":150,"targetDuration":10,"studyType":153,"phases":10,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"BioFire Defense LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Suspected respiratory infection",null,"NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider",[13],"Device: Investigational IVD for coronaviruses",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Investigational IVD for coronaviruses","Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care\u002Fmanagement.",[9],[21],"BIOFIRE ECoV Panel",[23],{"name":24,"affiliation":5,"role":25},"Brittany C Collins, PhD","PRINCIPAL_INVESTIGATOR",[27,31],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","801-262-3592","brittany.collins@biofiredefense.com",{"name":32,"role":28,"phone":29,"phoneExt":10,"email":33},"David Rabiger, PhD","david.rabiger@biofiredefense.com",[35,54,69,85,100,115],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Children's Hospital Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":52,"phoneExt":10,"email":53},"Jenn Dien Bard, PhD D(ABMM) F(CCM)","(323) 361-5443","jdienbard@chla.usc.edu",{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"George Washington University","Washington D.C.","District of Columbia","20037",{"type":44,"coordinates":60},[61,62],-77.03637,38.89511,{"lat":62,"lon":61},[65],{"name":66,"role":28,"phone":67,"phoneExt":10,"email":68},"Aileen Chang, MD MSPH FACP","(202) 677-6562","chang@gwu.edu",{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":41,"countryCode":42,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Tampa General Hospital","NOT_YET_RECRUITING","Tampa","Florida","33606",{"type":44,"coordinates":76},[77,78],-82.45843,27.94752,{"lat":78,"lon":77},[81],{"name":82,"role":28,"phone":83,"phoneExt":10,"email":84},"Suzane Silbert, PhD","(813) 844-4261","ssilbert@tgh.org",{"facility":86,"status":37,"city":87,"state":88,"zip":89,"country":41,"countryCode":42,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Emory University Hospital","Atlanta","Georgia","30032",{"type":44,"coordinates":91},[92,93],-84.38798,33.749,{"lat":93,"lon":92},[96],{"name":97,"role":28,"phone":98,"phoneExt":10,"email":99},"Colleen Kraft, MD MSc","(404) 712-8889","Colleen.kraft@emory.edu",{"facility":101,"status":71,"city":102,"state":103,"zip":104,"country":41,"countryCode":42,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Wake Forest University Health Sciences","Winston-Salem","North Carolina","27157-1042",{"type":44,"coordinates":106},[107,108],-80.24422,36.09986,{"lat":108,"lon":107},[111],{"name":112,"role":28,"phone":113,"phoneExt":10,"email":114},"John Williamson, PharmD","336-716-2700","john.williamson@advocatehealth.org",{"facility":116,"status":71,"city":117,"state":118,"zip":119,"country":41,"countryCode":42,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"University of Texas Medical Branch","Galveston","Texas","77550",{"type":44,"coordinates":121},[122,123],-94.7977,29.30135,{"lat":123,"lon":122},[126],{"name":127,"role":28,"phone":128,"phoneExt":10,"email":129},"Corri Levine, PhD MS MPH","(409) 747-1928","cblevine@utmb.edu",{"type":131,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[133,135,136,137,138,140],{"name":36,"class":134},"OTHER",{"name":55,"class":134},{"name":101,"class":134},{"name":70,"class":134},{"name":139,"class":134},"The University of Texas Medical Branch, Galveston",{"name":141,"class":134},"Emory University","100609939","prospective-clinical-evaluation-of-the-biofire-emerging-coronavirus-panel-for-the-detection-of-covid-19-and-other-coronaviruses-100609939",false,"NCT07221097","Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses","Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol","Inclusion Criteria:\n\n* Specimen is residual NPS in transport medium (VTM or UTM) left over from standard of care testing under clinician order for respiratory pathogen analysis.\n* Specimen has been held at room temperature for less than or equal to 4 hours or 4°C for less than or equal to 72 hours before enrollment.\n* At least 1.7 mL of specimen is remaining after standard of care testing and available for use in the study\n\nExclusion Criteria:\n\n* Specimen is unable to be tested within the defined storage parameters\n* Insufficient specimen volume for testing\n* Transport medium type is unknown","ALL",{"count":151,"type":152},1500,"ESTIMATED","OBSERVATIONAL","The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium.\n\nThis study aims to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highly sensitive and specific for the detection of the coronaviruses included on the panel.",[156,157,158],"Coronavirus","Respiratory Infection","COVID",[160,161,162,163,164],"in vitro diagnostic","pandemic preparedness","medical device","molecular diagnostic","coronavirus","2025-10-23",{"date":167,"type":168},"2025-10-27","ACTUAL",{"date":170,"type":168},"2025-09-29",{"date":172,"type":152},"2026-08",{"name":5,"class":6},6]