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Platform to Evaluate the Safety and Efficacy of post-exposure prophylaxis for viral hemorrhagic fevers sub-protocol 02:Favipiravir for patients exposed to Lassa virus

Evaluation of Prophylaxis Safety and Efficacy in Post-Exposure Patients with viral hemorrhagic sub-protocol 02:Favipiravir for patients exposed to Lassa virus

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240114
Enrollment
5
Registered
2024-05-27
Start date
2024-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of the onset of Lassa virus or Lassa fever in persons exposed to patients with Lassa viru Lassa fever

Interventions

Favipiravir was administered orally at 1,800 mg/dose twice, and 800 mg/dose twice daily thereafter for a total of 20 times

Sponsors

Morioka Shinichiro
Lead Sponsor
Ohmagari Norio
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 case enrollment 3. who have suffered a skin injury due to sharp instruments contaminated (or potentially contaminated) with Lassa virus 4. who has had mucous membranes or broken skin contaminated by a sample or specimen that is (or may be) contaminated with Lassa virus 5. a person who has been in contact with a confirmed (or suspected) patient with Lassa fever for more than 1 hour in an enclosed space without wearing appropriate infection protection 6. a person who performed emergency procedures such as cardiopulmonary resuscitation on a confirmed (or suspected) patient with Lassa fever without wearing appropriate infection protection equipment 7. Persons for whom the benefit of post-exposure prophylaxis has been determined by the principal (sub-investigator) to outweigh the risks of medication

Exclusion criteria

Exclusion criteria: 1. pregnant 2. who are breast-feeding and cannot commit to discontinuing breast-feeding 3.Those who are not currently breastfeeding and cannot be assured that they will not breastfeed. 4. women who cannot commit to use an effective contraceptive method during treatment and for 14 days after the end of treatment, and men who cannot commit to use an effective contraceptive method during treatment and for 7 days after the end of treatment 5. women who cannot commit to not donating eggs during treatment and for 14 days after the end of treatment, or men who cannot commit to not donating sperm for reproductive purposes during treatment and for 7 days after the end of treatment 6. men who cannot commit to not having sexual intercourse with a pregnant woman during treatment and for 7 days after the end of treatment 7. men with a history of serious hypersensitivity to any component of favipiravir 8. who have been exposed to the drug for more than 22 days 9. who have already developed Lassa fever 10. Persons whose inclusion in this study is deemed inappropriate by the principal (sub-investigator) 11. whose participation in the study is not in the best interest of the patient in the judgment of the principal (sub-investigator)

Design outcomes

Primary

MeasureTime frame
Percentage of participants in this study who developed Lassa fever during the study period

Secondary

MeasureTime frame
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

Contacts

Public ContactSho Saito

Japan Institute for Health Security(JIHS)

saito.s@jihs.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026