[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":40,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":39,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":39,"enrollmentInfo":68,"targetDuration":39,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":39,"overallStatus":78,"whyStopped":79,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Blessing Corporate Services, Inc","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Aralast NP + Antiviral Treatment + Standard of Care","EXPERIMENTAL","The investigational product is alpha1-proteinase inhibitor, administered as a loading dose of 120mg\u002Fkg\u002Fbody weight intravenous infusion on the first day, and then 60mg\u002Fkg\u002FBW intravenous infusion on Days 3, 5, 7 and 9. Booster infusion of 120 mg\u002Fkg\u002FBWon Day 17.\n\nThe Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and\u002For ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes\n\nStandard of Care treatments are at the investigator's discretion based on best practices.",[13,14],"Drug: alpha1-proteinase inhibitor","Drug: Antiviral Agents",{"label":16,"type":17,"description":18,"interventionNames":19},"Antiviral Treatment + Standard of Care","ACTIVE_COMPARATOR","The Antiviral treatment is Remdesivir. For patients not requiring invasive mechanical ventilation and\u002For ECMO, the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. Recommended dosage in adults and pediatric patients 12 years of age and older and weighing at least 40 kg: a single loading dose of Remdesivir 200 mg on Day 1 followed by once-daily maintenance doses of Remdesivir 100 mg from Day 2 infused over 30 to 120 minutes\n\nStandard of Care treatments are at the investigator's discretion based on best practices.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","alpha1-proteinase inhibitor","Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.",[9],[27],"Aralast NP",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Antiviral Agents","a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization",[16,9],[33],"Remdesivir",[35],{"name":36,"affiliation":37,"role":38},"Humam Farah, MD","Employee","PRINCIPAL_INVESTIGATOR",null,[41],{"facility":5,"status":39,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":39},"Hannibal","Missouri","63401","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-91.35848,39.70838,{"lat":51,"lon":50},{"type":54,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[56],{"name":57,"class":58},"Takeda Pharmaceuticals North America, Inc.","INDUSTRY","100414320","phase-3-aralast-np-with-antiviral-treatment-and-standard-of-care-versus-antiviral-treatment-with-standard-of-care-in-hospitalized-patients-with-pneumonia-and-covid-19-infection-100414320",false,"NCT04675086","Aralast NP With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection","A Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP, an Alpha-1 Antitrypsin Infusion Therapy With Antiviral Treatment and Standard of Care Versus Antiviral Treatment With Standard of Care in Hospitalized Patients With Pneumonia and COVID-19 Infection","Inclusion Criteria\n\n1. Subject will sign and date an informed consent form.\n2. Hospitalized subjects will be 18 years of age or older.\n3. Lab confirmed positive for COVID-19 within 72 hours prior to randomization.\n4. Subjects with COVID-19 with evidence of pneumonia (diagnosed by a chest x-ray) on supplemental oxygen or non-invasive ventilation with PO2\u002FFiO2 ratio less than 300.\n5. Subject must have one of the following elevated inflammatory markers: C-reactive protein \\>40mg\u002FL; D-Dimers \\> 250ng\u002FmL DDU or \\>0.5mcg\u002FmL FEU; Ferritin \\>400ng\u002FmL; LDH \\>300U\u002FL.\n\nExclusion Criteria\n\n1. Subject is on mechanical ventilation at time of screening.\n2. Subject is not expected to survive greater than 48 hours from screening based on PI judgement.\n3. Prior or current treatment with anti-IL-6, anti-IL-6 R antagonist or JAK inhibitors.\n4. Subject is on immunosuppressive agents, with the exception of corticosteroids for severe COVID-19 patients at the discretion of the PI.\n5. Subject is currently participating in a trial for any other investigational drug.\n6. Subject is on another plasma derived product or has received plasma or blood products within the last 48 hours.\n7. Subject is pregnant or breastfeeding.\n8. The subject, or the next of kin\u002Fpower of attorney are not able to give the proper informed consent.\n9. The subject has a known IgA deficiency with anti-IgA antibodies.\n10. Subject has a known Alpha-1 Antitrypsin Deficiency.\n11. Subject has antibodies against alpha-1 proteinase inhibitor\n12. Subject has renal, liver or multisystem organ failure\n13. Subject has known history of hypersensitivity following infusions of human blood or blood components (eg, human immunoglobulins or human albumin).\n14. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.","ALL","18 Years",{"count":69,"type":70},0,"ACTUAL","INTERVENTIONAL",[73],"PHASE3","This is a Randomized, Open-Label Study of the Efficacy and Safety of Aralast NP Infusion Therapy with Antiviral Treatment and standard of care versus Antiviral Treatment and standard of care (control group) in Hospitalized Patients with Pneumonia and COVID-19 Infection.",[76,77],"Covid19","Pneumonia, Viral","WITHDRAWN","Administrative Decision","2020-12-17",{"date":82,"type":70},"2020-12-21",{"date":84,"type":85},"2021-01","ESTIMATED",{"date":87,"type":85},"2021-12",{"name":5,"class":6},1]