[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100391942":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":33,"locations":19,"responsibleParty":42,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":19,"overallStatus":64,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":19},{"fullName":5,"class":6},"Assiut University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyper immunoglobulins have anti-Corona VS2 immunoglobulin","EXPERIMENTAL","safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients",[13],"Other: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"hyper immunoglobulins containing anti-Corona VS2 immunoglobulin","Prospective randomized clinical study for efficacy of anti-SARS-CoV-2 hyper immunoglobulins prepared from COVID19 convalescent plasma using VIPS Mini-Pool IVIG medical device",[9],null,[21,25,29,31],{"name":22,"affiliation":23,"role":24},"Maha A Mohamed, professor","Assiut univeristy","STUDY_DIRECTOR",{"name":26,"affiliation":27,"role":28},"Magdy El Ekiaby, Doctor","Sabrawishy hospital,Dokki,Giza,Egypt","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":23,"role":28},"Azza M Ez-Eldin, professor",{"name":32,"affiliation":23,"role":28},"Alia M Hussein, professor",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Alshaimaa M Selim, specialist","CONTACT","01003580480","shaimaamokhtargood@yahoo.com",{"name":22,"role":36,"phone":40,"phoneExt":19,"email":41},"01000004572","atwa_maha@yahoo.com",{"type":28,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Alshaimaa Mokhtar Selim mohamed","principal investigator","100391942","clinical-study-for-efficacy-of-anti-corona-vs2-immunoglobulins-prepared-from-covid19-convalescent-plasma-prepared-by-vips-mini-pool-ivig-medical-devices-in-prevention-of-sars-cov-2-infection-in-high-risk-groups-as-well-as-treatment-of-early-cases-of-covid19-patients-100391942",false,"NCT04383548","Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma Prepared by VIPS Mini-Pool IVIG Medical Devices in Prevention of SARS-CoV-2 Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients","Randomized Prospective Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma in Prevention of Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients","Inclusion Criteria:\n\na. Passive immunization group (Group A)\n\n1. 20 high risk exposed persons (HCPs) who are nasopharyngeal swab SARSCoV-2 PCR negative and seronegative for SARS-CoV-2 IgM\u002FIgG antibodies to receive prophylactic anti- SARS-CoV-2 hyper immunoglobulin. Selected population can be both male and female with age range 21 - 50 years b. 20 high risk persons (HCPs) who are nasopharyngeal swab SARS-CoV-2 PCR negative and seronegative for SARS-CoV-2 IgM\u002FIgG antibodies as control group. Selected population can be both male and female with age range 21 - 50 years\n2. Patient group (group B):\n\na. 30 patients with COVID19 disease and nasopharyngeal swab or sputum SARSCoV-2 positive PCR to receive anti-SARS-CoV-2 in addition to applied clinical management protocol. Selected test group can be male or female with age \\>20 years b. 30 patients with COVID-19 disease and nasopharyngeal swab or sputum SARS-CoV-2 PCR positive managed according to applied clinical management protocols of COVID-19 disease as control group. Selected test group can be male or female with age \\>30 years\n\nExclusion Criteria:\n\n1. Passive immunization group (Group A):\n\n   1. Age less than 21 or above 50 years\n   2. . Nasopharyngeal swab SARS-CoV-2 positive PCR\n   3. . Presence of anti-SARS-CoV-2 IgM, IgG\n   4. Presence of comorbidities such as hypertension, diabetes, chronic renal disease, previous thrombotic events or states of allergy such as urticaria or bronchial asthma as well as previous adverse events due to infusion of IVIG\n2. Patient group (group B):\n\n   1. Age less than 20 years\n   2. . SARS-CoV-2 PCR negative\n   3. . COVID-19 patients who may suffer from co morbidities such as hypertension, diabetes, chronic renal disease, thrombotic tendency or history of adverse events to IVIG as well as old age will be excluded to reduce the possibility of development of serious adverse events related to infusion of IVIG unless it will be for compassionate use in advanced stages of COVID-19 patients and after obtaining informed consent","ALL","21 Years","50 Years",{"count":56,"type":57},100,"ESTIMATED","INTERVENTIONAL",[60],"NA","Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to:\n\n1. To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19\n2. To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection",[63],"COVID19","UNKNOWN","2020-05-10",{"date":67,"type":68},"2020-05-12","ACTUAL",{"date":70,"type":57},"2020-06-01",{"date":72,"type":57},"2021-01-01",{"name":5,"class":6}]