Platform to Evaluate the Safety and Efficacy of post-exposure prophylaxis for viral hemorrhagic fevers sub-protocol 01:Remdesivir for patients exposed to Ebora virus

JRCT ID: jRCTs031240115

Registered date:27/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prevention of the onset of Ebola virus and Ebola hemorrhagic fever in persons exposed to Ebola patie
• Date of first enrollment: 01/06/2024
• Target sample size: 5
• Study type: Interventional

Intervention(s)

First day of treatment Initial dose 150 mg once daily by intravenous infusion
Dose Days 2 to 10 100 mg once daily by intravenous infusion

Outcome(s)

• Primary Outcome: Viral hemorrhagic fever at the end of the study or at the time of discontinuation, and the percentage of participants in the study who developed Ebola during the study period

Secondary Outcome

1. positive PCR test (blood) by the end of the study or at the time of discontinuation
2. positive viral antibody test by the end of the study or at the time of discontinuation
3. death at the end of the study or at the time of discontinuation
4. change over time of the following symptoms specific to viral hemorrhagic fever
High fever (39 to 41 degrees C), general malaise, major arthralgia, sore throat, cough, myalgia, epigastric pain, retrosternal pain, vomiting, nausea, diarrhea, abdominal pain, edema of the face and neck, hemorrhage of the conjunctiva of the eye

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. those who have given written consent to participate in the research
2. be at least 18 years of age at the time of enrollment
3. who have suffered skin injuries due to sharp instruments contaminated (or potentially contaminated) with Ebola viruses
4. a person whose mucous membranes or skin with a wound has been contaminated by a sample or specimen that is (or may be) contaminated with a Ebola virus
5. a person who has been in contact with a confirmed (or suspected) patient with Ebola virus for more than 1 hour in an enclosed space without wearing appropriate infection protective equipment
6. a person who performed emergency procedures such as cardiopulmonary resuscitation on a confirmed (or suspected) patient with Ebola virus without wearing appropriate infection protective equipment
7. Persons for whom post-exposure prophylaxis is deemed desirable by the Principal Investigator(s) as a situation equivalent to 3 to 6 above.

Exclude criteria

1. persons with known severe allergy to Remdecivir
2. Persons who already have Ebola
3. Persons deemed by the principal investigator or subinvestigator to be ineligible to participate in this study
4. Those who have been exposed for more than 22 days

Related Information

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