Platform to Evaluate the Safety and Efficacy of Treatments for Viral Hemorrhagic Fevers sub-protocol 02: mAb114 for Ebora Virus Patients

JRCT ID: jRCTs031240112

Registered date:27/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ebora Virus
• Date of first enrollment: 01/03/2025
• Target sample size: 5
• Study type: Interventional
• Intervention(s): A single 50 mg/kg dose of mAb114 (ansuvimab) is administered intravenously over 60 minutes.

Outcome(s)

• Primary Outcome: Mortality rates at Day 30 for patients diagnosed with Ebola hemorrhagic fever.

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include criteria

1. those who have given written consent to partici pate in the study
2. who have EV RNA detected by reverse-transcrip tase-polymerase-chain-reaction assay (RT-PCR) using blood, urine, or throat swab samples
3. Those for whom the principal investigator (sub-investigator) physician has determined that it is desirable to receive mAb114 (Ansuvimab)

Exclude criteria

Patients whose participation in the study is not in the best interest of the patient in the judgment of the principal investigator (sub-investigator)
2. patients whose inclusion in the study is deemed inappropriate by the principal investigator (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

Related Information

• Primary Sponsor: Morioka Shinichiro
• Secondary Sponsor: Ohmagari Norio,Health Labour Sciences Research Grant