A single-arm intervention trial to verify the efficacy of mAb114 against Ebola virus disease.
Not Applicable
- Conditions
- Ebola virus diseaseD019142
- Registration Number
- JPRN-jRCTs031220564
- Lead Sponsor
- Morioka Shinichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 5
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 28 days after study entry
- Secondary Outcome Measures
Name Time Method Mortality on days 14 and 56 after study entry.<br>Virological evaluation:<br>Blood viral load on days 1, 3, 7, 10, 14, and 28 after study entry.<br>Viral load in semen on days 28 and 56 after study entry.<br>Incidence of adverse events.