[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407195":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":10,"locations":35,"responsibleParty":134,"collaborators":136,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":10,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":148,"minAge":10,"maxAge":10,"enrollmentInfo":149,"targetDuration":10,"studyType":152,"phases":10,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":158,"whyStopped":10,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1",null,"Pregnant women hospitalized and receiving RDV for treatment of COVID-19.",[13],"Drug: Remdesivir",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Non-pregnant women of childbearing potential hospitalized and receiving RDV for treatment of COVID-19.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Remdesivir","RDV was not provided as part of the study. Participants were administered RDV intravenously once daily for up to 10 days per clinical care.",[9,15],[25,29,32],{"name":26,"affiliation":27,"role":28},"Mark Mirochnick, MD","Department of Pediatrics, Boston University Chobanian and Avedisian School of Medicine","STUDY_CHAIR",{"name":30,"affiliation":31,"role":28},"Diana Clarke, PharmD","Pediatric Infectious Diseases, Boston Medical Center",{"name":33,"affiliation":34,"role":28},"Brookie Best, PharmD, MAS","University of California, San Diego",[36,49,59,69,79,89,95,105,115,124],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":10},"David Geffen School of Medicine at UCLA (Site #: 5112)","Los Angeles","California","90095","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},{"facility":50,"status":10,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":10},"Childrens Hospital (U. Colorado, Denver) NICHD CRS (Site #: 5052)","Denver","Colorado","80218-1088",{"type":44,"coordinates":55},[56,57],-104.9847,39.73915,{"lat":57,"lon":56},{"facility":60,"status":10,"city":61,"state":62,"zip":63,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Pediatric Perinatal HIV Clinical Trials Unit (Site #: 5127)","Miami","Florida","33136",{"type":44,"coordinates":65},[66,67],-80.19366,25.77427,{"lat":67,"lon":66},{"facility":70,"status":10,"city":71,"state":72,"zip":73,"country":41,"countryCode":42,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Emory University School of Medicine (Site #: 5030)","Atlanta","Georgia","30308",{"type":44,"coordinates":75},[76,77],-84.38798,33.749,{"lat":77,"lon":76},{"facility":80,"status":10,"city":81,"state":82,"zip":83,"country":41,"countryCode":42,"cosmosGeoPoint":84,"geoPoint":88,"contacts":10},"Rush University Cook County Hospital NICHD CRS (Site #: 5083)","Chicago","Illinois","60612",{"type":44,"coordinates":85},[86,87],-87.65005,41.85003,{"lat":87,"lon":86},{"facility":90,"status":10,"city":81,"state":82,"zip":91,"country":41,"countryCode":42,"cosmosGeoPoint":92,"geoPoint":94,"contacts":10},"Lurie Children's Hospital of Chicago (LCH) CRS (Site #: 4001)","60614",{"type":44,"coordinates":93},[86,87],{"lat":87,"lon":86},{"facility":96,"status":10,"city":97,"state":98,"zip":99,"country":41,"countryCode":42,"cosmosGeoPoint":100,"geoPoint":104,"contacts":10},"Johns Hopkins University NICHD CRS (Site #: 5092)","Baltimore","Maryland","21287",{"type":44,"coordinates":101},[102,103],-76.61219,39.29038,{"lat":103,"lon":102},{"facility":106,"status":10,"city":107,"state":108,"zip":109,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":10},"Stony Brook University Medical Center (Site #: 5040)","Stony Brook","New York","11794",{"type":44,"coordinates":111},[112,113],-73.14094,40.92565,{"lat":113,"lon":112},{"facility":116,"status":10,"city":117,"state":108,"zip":118,"country":41,"countryCode":42,"cosmosGeoPoint":119,"geoPoint":123,"contacts":10},"Bronx-Lebanon Hospital Center (Site #: 5114)","The Bronx","10457",{"type":44,"coordinates":120},[121,122],-73.86641,40.84985,{"lat":122,"lon":121},{"facility":125,"status":10,"city":126,"state":127,"zip":128,"country":41,"countryCode":42,"cosmosGeoPoint":129,"geoPoint":133,"contacts":10},"Texas Children's Hospital (Site #: 5128)","Houston","Texas","77030",{"type":44,"coordinates":130},[131,132],-95.36327,29.76328,{"lat":132,"lon":131},{"type":135,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[137],{"name":138,"class":139},"Gilead Sciences","INDUSTRY","100407195","pk-and-safety-of-remdesivir-for-treatment-of-covid-19-in-pregnant-and-non-pregnant-women-in-the-us-100407195",true,"NCT04582266","PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US","Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States","Inclusion Criteria: Arm 1 (Pregnant Women)\n\n* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant\n* At study entry, viable intra-uterine pregnancy of any gestational age, based on medical records.\n* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.\n* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.\n\nInclusion Criteria - Arm 2 (Non-Pregnant Women)\n\n* Of legal age or otherwise able to provide independent informed consent or is unable to provide informed consent (e.g., impaired capacity) and a Legally Authorized Representative (LAR) is willing and able to provide written informed consent on behalf of the participant\n* At study entry, between 18 and 45 years of age, based on medical records and participant report.\n* Assigned female at birth and at study entry not taking cross-sex hormone therapy.\n* At study entry, not suspected to be pregnant, based on participant report and\u002For investigator or designee determination.\n* At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical records.\n* At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as prescribed by the clinical care provider and documented in medical records.\n\nExclusion Criteria:\n\n* At study entry, has started or received the 4th RDV infusion.\n* At study entry, evidence of post-menopausal status (medical or surgical), based on medical records and\u002For participant report.\n* At study entry, any contraindications to RDV treatment for COVID-19, based on investigator or designee determination.\n* Received or administered any disallowed medications within 48 hours prior to study entry.\n* At study entry, has any other condition, that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.",false,"FEMALE",{"count":150,"type":151},54,"ACTUAL","OBSERVATIONAL","IMPAACT 2032 was a Phase IV prospective, open label, non-randomized opportunistic study. The objectives of this study were to describe the pharmacokinetic (PK) properties and safety of remdesivir (RDV) administered intravenously as part of clinical care among hospitalized pregnant and non-pregnant women of childbearing potential with coronavirus disease of 2019 (COVID-19). RDV was provided and managed by the participant's treating physician and was not provided as part of this study.",[155],"COVID-19",[157],"COVID-19, Pregnancy","COMPLETED","2023-05-16",{"date":161,"type":151},"2023-06-09",{"date":163,"type":151},"2021-03-31",{"date":165,"type":151},"2022-04-13",{"name":5,"class":6},10]