A single-arm intervention trial to verify the efficacy of mAb114 against Ebola virus disease.

JRCT ID: jRCTs031220564

Registered date:01/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ebola virus disease
• Date of first enrollment: 01/06/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): MAb114 will be given as a single dose. The observation period will be 56 days after inclusion in this study.

Outcome(s)

• Primary Outcome: Mortality 28 days after study entry

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Morioka Shinichiro
• Secondary Sponsor: Japan Agency for Medical Research and Development (AMED),Ministry of Health, Labour, and Welfare