Single arm intervention study to test the efficacy of REGN-EB3 against Ebola hemorrhagic fever

JRCT ID: jRCTs031220565

Registered date:01/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ebola hemorrhagic fever
• Date of first enrollment: 01/06/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): A single dose will be administered. In principle, the observation period will be 56 days from the date of inclusion in the study. The observation period will be terminated in the event of the death of the research subject. Participants in this study will be admitted to the National Center for Global Health and Medicine Hospital and will continue health observation in the outpatient clinic of the hospital after discharge.

Outcome(s)

• Primary Outcome: Mortality at 28 days after study inclusion

Secondary Outcome

Mortality at 14 and 56 days after inclusion in the study
Virus levels in blood at 1 3 7 10 14 and 28 days after inclusion
Virus levels 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) Persons who have given written consent to participate in the research.
However, those who meet the conditions described in 18.2 may participate in this research without prior consent.
(1) There is an immediate and obvious danger to the life of the person who is to be the subject of the specified clinical research.
(2) Other treatment methods cannot be expected to be sufficiently effective (even if they can be expected to be as effective as ordinary medical treatment or life-saving treatment, etc.).
(iii) That the Specific Clinical Research to be conducted is not in the best interests of the subject of the Clinical Research.
(iii) It is recognized that there is a sufficient possibility of avoiding a risk to life by conducting the said Specified Clinical Research.
(iii) The possibility of avoiding a life-threatening situation by conducting the specified clinical research is considered sufficient.
(iv) The anticipated disadvantages to the subjects of the Specified Clinical Research are the minimum necessary.
(iv) The anticipated disadvantages to the person who should be the subject of the specified clinical research are the minimum necessary.
(v) It is not possible to immediately contact the person who is to be the surrogate.
When the situation becomes such that the subject of the clinical research and the surrogate can be explained, an explanation of the said clinical research should be given promptly and consent should be obtained in writing.

2) Persons whose EV RNA is detected by reverse-transcriptase-polymerase-chain-reaction assay (RT-PCR) test using blood, urine, or throat swab samples

Exclude criteria

1) Subjects deemed inappropriate for inclusion in the study by the Principal Investigator or Research Supervisor
2) Patients for whom administration of the drug is considered inappropriate based on the attached document or other documents equivalent to the investigational new drug summary
3) Patients with a history of serious hypersensitivity to this drug

Related Information

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