An open-label, single-arm study to investigate the efficacy of Favipiravir on Lassa Fever for Post Exposure Prophylaxis

JRCT ID: jRCTs031230118

Registered date:01/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Lassa fever
• Date of first enrollment: 01/12/2023
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Favipiravir 1800 mg/dose twice, then 800 mg/dose twice daily for a total of 10 days orally.

Outcome(s)

• Primary Outcome: Lassa fever at the end of the study or at the time of discontinuation

Secondary Outcome

1) Death at the end of the study or at the time of discontinuation
2) Positive PCR test (blood) by the end of the study or at the time of discontinuation
3) Positive viral antibody test at the end of the study or by the time of discontinuation
4) Change over time in the presence or absence of the following symptoms characteristic of Lassa fever
-High fever (39-41degrees) -General malaise
-Large joint pain -Sore throat -Cough
-Myalgia -Orbital pain -Retrosternal pain
-Vomiting -Nausea -Diarrhea
-Abdominal pain -Facial and cervical edema -Ocular conjunctival hemorrhage
-Gastrointestinal hemorrhage -Carditis -Pleurisy -Shock
-Unilateral or bilateral deafness
5) Safety
-Adverse events
-General laboratory tests (blood, urine) -Weight
-Vital signs

Key inclusion & exclusion criteria

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

Include criteria

1)Has given written consent to participate in the study
2)18 years of age or older at the time consent is given
3)Has a skin injury from a sharp instrument contaminated (or suspicious to be so) with Lassa virus.
4)Whose the mucous membranes or damaged skin has been contacted with a sample contaminated with Lassa virus.
5)Contacted with a patient with Lassa fever (or who is suspicious to be so) within a confined space without wearing appropriate protective equipment.
6)Performed emergent intervention such as cardiopulmonary resuscitation without wearing appropriate protective equipment.
7)Other situation in relation to 1)-4) above, those considered to be adequate for post exposure prophylaxis by principle/sub investigator.

Exclude criteria

1) Prengant patient
2) Those who are breast-feeding and cannot promise to stop breast-feeding during and for 7 days after the end of administration
3) Unable to commit to using an effective contraceptive method during treatment and for 14 days after completion of treatment for women and during treatment and for 7 days after completion of treatment for men
4) Women who cannot commit to not donating eggs during treatment and for 14 days after completion of treatment, or men who cannot commit to not donating sperm for reproductive purposes during treatment and for 7 days after completion of treatment
5) Those who cannot promise not to have sexual intercourse with pregnant women during and for 7 days after completion of administration
6) Persons with a history of severe hypersensitivity to the ingredients of Favipiravir
7) More than 22 days after exposure
8) Those that have already developed Lassa fever
9) Judged illegible to participate in the study by the principal investigator or sub-investigator

Related Information

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