[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504976":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":38,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":38,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":38,"overallStatus":47,"whyStopped":38,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Emory University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"L-arginine loading dose + standard dose","ACTIVE_COMPARATOR","L-arginine loading dose (200 mg\u002Fkg IV) + standard dose (100 mg\u002Fkg IV TID).",[13],"Drug: Arginine Hydrochloride",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard dose","Standard dose (100mg\u002Fkg IV TID).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Low dose","Low dose (25mg\u002Fkg IV TID).",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Arginine Hydrochloride","Arginine will be infused based on the manufacturer's instructions (R-Gene 10, Pfizer), over 30 minutes. However, rates may be slowed to over 60 minutes for patients experiencing symptoms of flushing, nausea, vomiting, or headache at the research team's discretion. Pediatric doses will be drawn up by the pharmacy.",[9,19,15],[29],"L-arginine",[31],{"name":32,"affiliation":5,"role":33},"Claudia R. Morris, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","404 727-5500",null,"claudia.r.morris@emory.edu",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Dunia Hatabah, MD","470-6626706","dunia.hatabah@emory.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Children's Healthcare of Atlanta (CHOA), Arthur M. Blank","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.38798,33.749,{"lat":57,"lon":56},[60,63],{"name":61,"role":36,"phone":37,"phoneExt":38,"email":62},"Claudia R Morris, MD","claudia.morris@choa.org",{"name":64,"role":33,"phone":38,"phoneExt":38,"email":38},"Caludia R Morris, MD",{"type":33,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Claudia R. Morris","Professor of Medicine","100504976","phase-2-arginine-replacement-therapy-in-covid-19-100504976",false,"NCT05855330","Arginine Replacement Therapy in COVID-19","Prospective Open-Label Pilot Study of Arginine Replacement Therapy in Children Hospitalized With COVID-19","ART-COVID19","Inclusion Criteria:\n\n* Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection\n* Age 3 years - 21 years of age\n\nExclusion Criteria:\n\n* Severe hepatic dysfunction: ALT\\> 6 x Upper limit of normal\n* Renal dysfunction: Creatinine \\> 1.5 x upper limit of normal or on dialysis\n* Acute Stroke\n* Pregnancy\n* Allergy to arginine\n* Past history of severe cardiac disease or significant cardiac surgery \\[minor procedures like ventricular septal defect (VSD) repair are not an exclusion\\]\n* History of significant pulmonary disease \\[Cystic Fibrosis, sickle cell disease (SCD)\\]\n* History of organ transplant\n* History of metabolic or mitochondrial disease (including Diabetes)\n* History of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury)\n* History of ventriculoperitoneal (VP) shunt or hydrocephalus\n* PI discretion that the patient is not an ideal candidate for the study\n* History of HIV of immune compromise","ALL","3 Years","21 Years",{"count":80,"type":81},21,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19.\n\nThe study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.",[87],"COVID-19","2026-04-10",{"date":90,"type":91},"2026-04-15","ACTUAL",{"date":93,"type":91},"2024-01-08",{"date":95,"type":81},"2028-06",{"name":5,"class":6},1]