[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416949":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":37,"locations":31,"responsibleParty":45,"collaborators":31,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":31,"enrollmentInfo":57,"targetDuration":31,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":31,"overallStatus":68,"whyStopped":31,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":31},{"fullName":5,"class":6},"Sinocelltech Ltd.","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"SCTA01 low dose +SOC","EXPERIMENTAL","SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody",[13],"Drug: SCTA01",{"label":15,"type":10,"description":11,"interventionNames":16},"SCTA01 middle dose+SOC",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SCTA01 High dose +SOC",[13],{"label":21,"type":22,"description":11,"interventionNames":23},"Placebo+SOC","PLACEBO_COMPARATOR",[24],"Other: Placebo",[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","SCTA01","Diluted by 0.9% normal saline，IV",[18,9,15],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"OTHER","Placebo","IV",[21],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":31,"email":42},"Qiang Guo, PhD","CONTACT","86-10-5862 8288","qiang_guo@sinocelltech.com",{"name":44,"role":40,"phone":31,"phoneExt":31,"email":31},"Zhanghua Lan, PhD",{"type":46,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100416949","phase-2-to-evaluate-scta01-treatment-of-high-risk-outpatients-with-covid-19-100416949",false,"NCT04709328","To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19","An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II\u002FIII Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)","MAOP3","Inclusion Criteria:\n\n* Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;\n* Participants should have at least one of COVID-19 risk factor;\n* Participants should have at least 2 COVID-19 related symptoms;\n* Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤7 days before randomization;\n* First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;\n* Participants are currently not hospitalized;\n* Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;\n* Women with childbearing potential must agree to use effective contraceptive methods during the study period;\n* Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.\n\nExclusion Criteria:\n\n* Have known allergies to any of the components used in the formulation of the SCTA01\u002Fplacebo;\n* Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;\n* Have SpO2 ≤ 93% on room air at sea level or PaO2\u002FFiO2 \\\u003C 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);\n* Require mechanical ventilation or anticipated impending need for mechanical ventilation;\n* Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;\n* Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;\n* Have any co-morbidity requiring surgery within \\\u003C29 days, or that is considered life threatening within 29 days;\n* Have a history of previous SARS-CoV-2 infection;\n* Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;\n* Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;\n* Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;\n* Pregnant or lactating women;\n* Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;\n* Participants unable to follow the protocol during the study;\n* Participants deemed inappropriate for enrollment by the investigator due to other factors.","ALL","18 Years",{"count":58,"type":59},690,"ESTIMATED","INTERVENTIONAL",[62,63],"PHASE2","PHASE3","The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II\u002FIII clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.",[66,67],"COVID-19","SARS-CoV-2","NOT_YET_RECRUITING","2021-03-24",{"date":71,"type":72},"2021-03-29","ACTUAL",{"date":74,"type":59},"2021-03-28",{"date":76,"type":59},"2022-03-01",{"name":5,"class":6}]