Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

Not Applicable

• Registration Number: PER-035-10
• Lead Sponsor: Toyama Chemical Co., Ltd.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1.Patients who test positive for influenza A or B by a commercially available Rapid
Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still
enroll if the sponsor and investigator agree that there is a known influenza outbreak
circulating in the community.

2.Patients = 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or
more; patients = 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or
more at the first visit, or in the 6 hours prior if antipyretics were taken.
3. Patients with 2 or more of the following symptoms (moderate to severe in intensity)
at the time of enrollment:

- Cough
- Sore throat
- Headache
- Nasal congestion
- Feeling feverish
- Body aches and pains
- Fatigue (tiredness)

Exclusion Criteria

1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed
under the inclusion criteria) for 36 hours or more prior to study screening.
2.Patients who have underlying chronic respiratory disease (e.g., chronic obstructive
pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis,
bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old
tuberculosis)
3. Patients who at the beginning of the study are suspected of having bacterial
respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or
infiltrate in lung in a chest x-ray, etc.).
4. Patients who have serious chronic diseases. For example, patients with HIV, cancer
(i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage),
and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic
disease states requiring medication dose adjustments within the last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified