[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499432":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":49,"collaborators":53,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":83,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Keralty Hospital, Miami","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Sesderma LACTYFERRIN™ Forte (64mg\u002F20ml, TID) and Sesderma ZINC Defense™ (20mg\u002F20ml QD) + SOC (N=20).",[13],"Drug: Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Placebo +SOC (N=20)",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™","Sesderma LACTYFERRIN™ Forte (64mg\u002F20ml, TID) and Sesderma ZINC Defense™ (20mg\u002F20ml QD)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Placebo)",[15],[32],{"name":33,"affiliation":5,"role":34},"Jose D Suarez","PRINCIPAL_INVESTIGATOR",[36],{"facility":37,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Keralty Hospital Miami","Miami","Florida","33155","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-80.19366,25.77427,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Jose David Suarez, MD","Principal investigator",[54,57,59],{"name":55,"class":56},"Sesderma S.L.","UNKNOWN",{"name":58,"class":56},"Westchester General Hospital Inc. DBA Keralty Hospital Miami",{"name":60,"class":56},"MGM Technology Corp","100499432","phase-2-lactyferrin-forte-and-zinc-defense-and-standard-of-care-soc-vs-soc-in-the-treatment-of-non-hospitalized-patients-with-covid-19-100499432",false,"NCT05783180","LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19","A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19","INCLUSION CRITERIA\n\n* Patient or legally authorized representative must be willing to sign an informed consent.\n* Male or female ≥18 years of age at the time of enrollment.\n* COVID-19 diagnosis confirmed by SARS-CoV-2 detection by polymerase chain reaction (PCR) or other commercial or public health assays in any specimen documented by any of the following:\n* PCR positive in samples collected ≤ 72h.\n* PCR positive in samples collected \\>72h and less than 7 days of disease progression.\n* Mild to moderate symptoms of COVID-19 as determined by investigators following the criteria from NIH COVID 19 Treatment Guidelines for (APPENDIX I. SEVERITY OF ILLNESS CATEGORIES).\n\nEXCLUSION CRITERIA\n\n* Hospitalized patients.\n* Breast-feeding or pregnant (any woman of childbearing age and potential must have a negative test within 24 hours of starting treatment).\n* Allergy to any of the components of the study medication.\n* AST or ALT \\> x3 the upper limit value\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30\n* Concomitant antiviral therapy such as lopinavir or ritonavir\n* Concomitant immunosuppressive or immunomodulatory drugs (e.g., interleukins, interleukin antagonists or receptor blockers, anticancer drugs, immunosuppressant)\n* Concomitant therapy with corticosteroids at a dose \\> 20mg per day was administered for more than 14 days before the study medication.\n* Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART).\n* Has participated in another clinical trial within the last 30 days.","ALL","18 Years",{"count":71,"type":72},0,"ACTUAL","INTERVENTIONAL",[75],"PHASE2","The goal of this clinical trial is to learn about the safety and efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ in non-hospitalized patients with COVID-19.\n\nThe main question is:\n\nIs there a reduction in the signs and symptoms of COVID-19 from baseline to end of treatment? Participants will complete the following activities.\n\n* Screening and first day of treatment\n* Treatment that will be administered for up to 10 days, two treatment evaluation visits will be completed\n* After treatment completion. Two visits are scheduled, one 28 days after the last dose and the other 60 days after the last dose.\n\nResearchers will compare Treatment Group (Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ + Standard of care (SOC)) with the Control group (Placebo +SOC) to see if there is Reduction in the signs and symptoms of COVID-19 at the end of treatment",[78],"COVID-19",[80,81,78],"Liposomal lactoferrin","liposomal Zinc","WITHDRAWN","Sponsor decided not to move forward with the trial","2023-11-08",{"date":86,"type":72},"2023-11-13",{"date":88,"type":89},"2023-06","ESTIMATED",{"date":91,"type":89},"2024-11",{"name":51,"class":6},1]