grant
ON BEHALF OF NIAID-DCR, FACILITATE THE CONDUCT OF TWO, RANDOMIZED TRIALS AS DETAILED BELOW IN I AND II:I. A RANDOMIZED BLINDED CONTROLLED TRIAL OF TH
Organization LEIDOS BIOMEDICAL RESEARCH, INC.Location FREDERICK, UNITED STATESPosted 3 Apr 2020Deadline 31 Jul 2028
NIHUS FederalResearch GrantFY202421+ years oldAdultAdult HumanBlindedCOVID infected patientCOVID patientCOVID positive patientCOVID-19COVID-19 infected patientCOVID-19 patientCOVID-19 positive patientCOVID19 patientCOVID19 positive patientCV-19CategoriesClinicalClottingCoagulationCoagulation ProcessConsentCoronaviridaeCoronavirusCoronavirus Infectious Disease 2019DataDisease ProgressionDrugsDysfunctionEnrollmentEnsureFunctional disorderFundingFutureGS-5734Hospital AdmissionHospitalizationIGIVIV ImmunoglobulinsIVIGImmune GlobulinsImmune globulin IVImmunoglobulinsInpatientsInternationalIntravenous AntibodiesIntravenous IGIntravenous Immune GlobulinIntravenous ImmunoglobulinsInvestigatorsLifeMedicalMedicationNIAIDNational Institute of Allergy and Infectious DiseaseOrganOrgan failureOutcomeParticipantPatientsPharmaceutical PreparationsPhysiopathologyPlacebosProtocolProtocols documentationRandomization trialRandomizedResearch PersonnelResearchersRespiration DisordersRespiratory DisorderSARS-CoV-2 infected patientSARS-CoV-2 patientSARS-CoV-2 positive patientSafetySample SizeSham TreatmentSiteSymptomsVekluryadulthoodbreathing disordercorona viruscoronavirus disease 2019coronavirus disease 2019 infected patientcoronavirus disease 2019 patientcoronavirus disease 2019 positive patientcoronavirus disease infected patientcoronavirus disease patientcoronavirus disease positive patientcoronavirus disease-19coronavirus disease-19 patientcoronavirus infectious disease-19coronavirus patientdouble-blind placebo control trialdouble-blind placebo controlled trialdouble-masked controlled trialdrug/agentenrollindividual patientmortalityparticipant enrollmentpathophysiologypatient enrollmentpatient infected with COVIDpatient infected with COVID-19patient infected with SARS-CoV-2patient infected with coronavirus diseasepatient infected with coronavirus disease 2019patient infected with severe acute respiratory syndrome coronavirus 2patient with COVIDpatient with COVID-19patient with COVID19patient with SARS-CoV-2patient with coronavirus diseasepatient with coronavirus disease 2019patient with severe acute respiratory distress syndrome coronavirus 2preventpreventingprimary end pointprimary endpointrandomisationrandomizationrandomized trialrandomly assignedremdesivirrespiratory dysfunctionsevere acute respiratory syndrome coronavirus 2 infected patientsevere acute respiratory syndrome coronavirus 2 patientsevere acute respiratory syndrome coronavirus 2 positive patientsham therapystandard of carestudy population
Description preview
This funding supports INSIGHT Protocol Number: 013, Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC). It is an international multicenter, adaptive, randomized double-blind, placebo-controlled trial of the safety, tolerability, and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin for the treatment of adult…
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