Ebora Virus Ebora Virus
Conditions
Interventions
Single dose of 50 mg/kg atoltivimab, 50 mg/kg maftivimab, 50 mg/kg odesivimab
Intravenous administration
Sponsors
Morioka Shinichiro
Ohmagari Norio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. those who have given written consent to participate in the study 2. who have EV RNA detected by reverse-transcriptase-polymerase-chain-reaction assay (RT-PCR) using blood, urine, or throat swab samples 3. Persons for whom REGN-EB3 administration is deemed desirable by the principal (sub-investigator)
Exclusion criteria
Exclusion criteria: 1.Patients whose participation in the study is not in the best interest of the patient in the judgment of the principal (sub-investigator) 2. Persons whose inclusion in this study is judged to be inappropriate by the principal (sub-investigator) 3. Persons for whom administration is considered inappropriate based on documents similar to the package insert 4. Patients with a history of severe hypersensitivity to this drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality rates at Day 30 for patients diagnosed with Ebola hemorrhagic fever. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality at 14 and 60 days after inclusion in the study 2. Virological evaluation - Blood viral load on days 1,3,7,10,14 and 30 after inclusion in the study - Virus levels in urine and throat swabs on days 1,3,7,10,14 and 30 after inclusion in the study - Virus levels in semen on days 60 and 120 after inclusion in the study 3. Incidence of adverse events | — |
Contacts
Public ContactSho Saito
Japan Institute for Health Security(JIHS)
Outcome results
None listed