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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Drug: Placebo comparator; Drug: Favipiravir

• Registration Number: NCT01068912
• Lead Sponsor: MDVI, LLC

Brief Summary

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

Detailed Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Results First Submitted: 2014-02-11
• Results First Submitted QC: 2014-02-11
• Results First Posted: 2014-03-27
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo comparator	Placebo
2: Experimental	Favipiravir	High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
1: Experimental	Favipiravir	Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days

Primary Outcome Measures

Name	Time	Method
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza	22 weeks	Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.

Trial Locations

Locations (227)

#065; 🇺🇸 Birmingham, Alabama, United States

#156; 🇺🇸 Huntsville, Alabama, United States

#151; 🇺🇸 Mobile, Alabama, United States

#155; 🇺🇸 Scottsboro, Alabama, United States

#173; 🇺🇸 Toney, Alabama, United States

#161; 🇺🇸 Tuscumbia, Alabama, United States

#089; 🇺🇸 Chandler, Arizona, United States

#018; 🇺🇸 Green Valley, Arizona, United States

#110; 🇺🇸 Mesa, Arizona, United States

#105; 🇺🇸 Phoenix, Arizona, United States

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