Ebola virus disease
Conditions
Interventions
MAb114 will be given as a single dose. The observation period will be 56 days after inclusion in this study.
Sponsors
Morioka Shinichiro
Japan Agency for Medical Research and Development (AMED)
Ministry of Health, Labour, and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who have given written informed consent to participate in the study 2) Subjects whose EV RNA was detected by reverse-transcriptase-polymerase-chain-reaction assay (RT-PCR) test using blood, urine, or throat swab samples.
Exclusion criteria
Exclusion criteria: 1) Persons who are judged inappropriate for inclusion in this research by the research representative or co-investigators 2) Subjects who are considered inappropriate for administration based on the package insert or documents equivalent to the investigator's brochure (3) Patients who have had a severe hypersensitivity reaction to Clozapine should not be administered the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality 28 days after study entry | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality on days 14 and 56 after study entry. Virological evaluation: Blood viral load on days 1, 3, 7, 10, 14, and 28 after study entry. Viral load in semen on days 28 and 56 after study entry. Incidence of adverse events. | — |
Contacts
Public ContactSho Saito
National Center for Global Health and Medicine
Outcome results
None listed