[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394145":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":31,"locations":36,"responsibleParty":90,"collaborators":31,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":31,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":31,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":115,"whyStopped":116,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tofacitinib","EXPERIMENTAL","Participants will receive tofacitinib 10 mg twice per day for 14 days and standard of care therapy.",[13],"Drug: Tofacitinib",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive tofacitinib-matching placebo twice per day for 14 days and standard of care therapy.",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days",[9],[26],"xeljanz",{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"OTHER","Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days",[15],null,[33],{"name":34,"affiliation":5,"role":35},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[37,50,60,65,75,80],{"facility":38,"status":31,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":31},"Hartford Hospital (HH)","Hartford","Connecticut","06102","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-72.68509,41.76371,{"lat":48,"lon":47},{"facility":51,"status":31,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":31},"University of Iowa Hospitals & Clinics Investigational Drug Services","Iowa City","Iowa","52242",{"type":45,"coordinates":56},[57,58],-91.53017,41.66113,{"lat":58,"lon":57},{"facility":61,"status":31,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":64,"contacts":31},"University of Iowa",{"type":45,"coordinates":63},[57,58],{"lat":58,"lon":57},{"facility":66,"status":31,"city":67,"state":68,"zip":69,"country":42,"countryCode":43,"cosmosGeoPoint":70,"geoPoint":74,"contacts":31},"LSUHSC-Shreveport","Shreveport","Louisiana","71103",{"type":45,"coordinates":71},[72,73],-93.75018,32.52515,{"lat":73,"lon":72},{"facility":76,"status":31,"city":67,"state":68,"zip":69,"country":42,"countryCode":43,"cosmosGeoPoint":77,"geoPoint":79,"contacts":31},"Ochsner LSU Health Shreveport Academic Medical Center",{"type":45,"coordinates":78},[72,73],{"lat":73,"lon":72},{"facility":81,"status":31,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":31},"University Hospitals Cleveland Medical Center","Cleveland","Ohio","44106",{"type":45,"coordinates":86},[87,88],-81.69541,41.4995,{"lat":88,"lon":87},{"type":91,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100394145","phase-2-safety-and-efficacy-of-tofacitinib-in-hospitalized-participants-with-covid-19-pneumonia-who-are-receiving-standard-of-care-therapy-100394145",false,"NCT04412252","Safety and Efficacy of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia Who Are Receiving Standard of Care Therapy","A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY ASSESSING THE SAFETY AND EFFICACY OF TOFACITINIB IN HOSPITALIZED PARTICIPANTS WITH COVID-19 PNEUMONIA WHO ARE RECEIVING STANDARD OF CARE THERAPY","Inclusion Criteria:\n\n* Male or female between 18 and 65 years. A female is eligible if she is not pregnant or breastfeeding. WOCBP must use 2 highly effective forms of contraception.\n* Participants with laboratory-confirmed novel coronavirus (SARS-CoV-2) infection prior to Day 1.\n* Participants with evidence of COVID-19 pneumonia assessed by radiographic imaging (chest x ray or chest CT scan).\n\nExclusion Criteria:\n\n* Require HFNC, non-invasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.\n* Have history of or current thrombosis. Only if current thrombosis is suspected, imaging testing is recommended (e.g. CTPA or per local guidance) to exclude thrombosis.\n* Have a personal or first degree family history of blood clotting disorders.\n* Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (e.g. azathioprine, cyclosporine).\n* Participants with any current malignancy or lymphoproliferative disorders that requires active treatment.\n* Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19).\n* Severe hepatic impairment, defined as Child-Pugh class C.\n* Severe anemia (hemoglobin \\\u003C 8 g\u002FdL)\n* ANY of the following abnormalities in clinical lab tests at screening, confirmed by a single repeat, if deemed necessary: ALC \\\u003C 500 cells\u002Fmm3, ANC \\\u003C 1000 cells\u002Fmm3\n* Known allergy to tofacitinib","ALL","18 Years","99 Years",{"count":103,"type":104},0,"ACTUAL","INTERVENTIONAL",[107],"PHASE2","The study is designed as a multicenter, randomized, double-blind, placebo-controlled, parallel group study of the safety and efficacy of tofacitinib in hospitalized adult participants with COVID-19 pneumonia who are receiving SoC therapy and who are not on HFNC, noninvasive ventilation, invasive mechanical ventilation, or ECMO on Day 1 at the time of randomization.\n\nParticipants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR or other commercially available or public health assay, who have agreed to participate will be screened within 48 hours after hospitalization to determine eligibility. This should be completed within 48 hours prior to Day 1.\n\nEligible participants will be randomized on Day 1 in a 1:1 ratio to the tofacitinib treatment group or the placebo treatment group and will receive treatment for up to 14 days, or until discharge from the hospital, whichever is earlier. If a participant requires intubation prior to the end of the 14-day treatment period, they will continue to receive tofacitinib or matching placebo until Day 14 (or until discharge from the hospital, if earlier than Day 14), if clinically appropriate.\n\nParticipants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 28, 28 to 35 days after the ET\u002FED\u002FEOT visit, and on Day 60.\n\nAn independent, external DSMB will be convened to oversee the safety of participants and make recommendations regarding the conduct of the trial in accordance with the Charter.",[110],"COVID-19",[110,112,113,114],"Pneumonia","SARS-CoV-2","Novel Coronavirus","WITHDRAWN","Due to the pursuit of other SARS-CoV-2-related research including alternative trials with tofacitinib, this trial was canceled prior to subject enrollment.","2020-07-29",{"date":119,"type":104},"2020-07-31",{"date":121,"type":122},"2020-07-06","ESTIMATED",{"date":124,"type":122},"2020-10-18",{"name":5,"class":6},6]