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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

530

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Feb 2010

Geographic Reach

7 countries

228 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

February 1, 2010

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

March 27, 2014

Completed

Last Updated

November 18, 2015

Status Verified

October 1, 2015

Enrollment Period

2.2 years

First QC Date

February 12, 2010

Results QC Date

February 11, 2014

Last Update Submit

October 20, 2015

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
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.
22 weeks

Study Arms (3)

1: Experimental

EXPERIMENTAL

Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days

Drug: Favipiravir

2: Experimental

EXPERIMENTAL

High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days

Drug: Favipiravir

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo comparator

Interventions

FavipiravirDRUG

1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days

1: Experimental

Placebo comparatorDRUG

Placebo BID x 1 day, and Placebo BID x 4 days

Placebo

Eligibility Criteria

Age20 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.
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)

You may not qualify if:

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).
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.).
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MDVI, LLClead

Study Sites (228)

#065

Birmingham, Alabama, United States

Location

#156

Huntsville, Alabama, United States

Location

#151

Mobile, Alabama, United States

Location

#155

Scottsboro, Alabama, United States

Location

#173

Toney, Alabama, United States

Location

#161

Tuscumbia, Alabama, United States

Location

#089

Chandler, Arizona, United States

Location

#018

Green Valley, Arizona, United States

Location

#110

Mesa, Arizona, United States

Location

#105

Phoenix, Arizona, United States

Location

#188

Tucson, Arizona, United States

Location

#107

Jonesboro, Arkansas, United States

Location

#019

North Little Rock, Arkansas, United States

Location

#140

Searcy, Arkansas, United States

Location

#059

Anaheim, California, United States

Location

#179

Anaheim, California, United States

Location

#032

Chino, California, United States

Location

#154

Cypress, California, United States

Location

#004

Garden Grove, California, United States

Location

#144

Long Beach, California, United States

Location

#043

Los Angeles, California, United States

Location

#139

Los Angeles, California, United States

Location

#096

Oxnard, California, United States

Location

#091

Pacific Palisades, California, United States

Location

#114

Pasadena, California, United States

Location

#111

Pico Rivera, California, United States

Location

#097

Pomona, California, United States

Location

#068

Sacramento, California, United States

Location

#035

San Diego, California, United States

Location

#054

San Diego, California, United States

Location

#042

Torrance, California, United States

Location

#197

Bridgeport, Connecticut, United States

Location

#022

Boca Raton, Florida, United States

Location

#152

Boynton Beach, Florida, United States

Location

#060

Coral Gables, Florida, United States

Location

#007

Delray Beach, Florida, United States

Location

#086

Edgewater, Florida, United States

Location

#016

Fort Myers, Florida, United States

Location

#038

Gainesville, Florida, United States

Location

#014

Hialeah, Florida, United States

Location

#052

Hialeah, Florida, United States

Location

#088

Hialeah, Florida, United States

Location

#035

Jacksonville, Florida, United States

Location

#094

Kissimmee, Florida, United States

Location

#153

Kissimmee, Florida, United States

Location

#177

Lauderdale Lakes, Florida, United States

Location

#012

Melbourne, Florida, United States

Location

#034

Miami, Florida, United States

Location

#040

Miami, Florida, United States

Location

#047

Miami, Florida, United States

Location

#082

Miami, Florida, United States

Location

#166

Miami, Florida, United States

Location

#149

Miami Gardens, Florida, United States

Location

#134

Pinellas Park, Florida, United States

Location

#050

Port Orange, Florida, United States

Location

#163

Venice, Florida, United States

Location

#020

West Palm Beach, Florida, United States

Location

#814

Snellville, Georgia, United States

Location

#080

Honolulu, Hawaii, United States

Location

#063

Boise, Idaho, United States

Location

#835

Oak Lawn, Illinois, United States

Location

#804

Fishers, Indiana, United States

Location

#803

Franklin, Indiana, United States

Location

#198

Greenfield, Indiana, United States

Location

#195

Munci, Indiana, United States

Location

#168

Council Bluffs, Iowa, United States

Location

#827

West Des Moines, Iowa, United States

Location

#008

Newton, Kansas, United States

Location

#138

Shawnee, Kansas, United States

Location

#106

Wichita, Kansas, United States

Location

#055

Hazard, Kentucky, United States

Location

#823

Alexandria, Louisiana, United States

Location

#801

Baton Rouge, Louisiana, United States

Location

#048

Elkridge, Maryland, United States

Location

#085

Silver Spring, Maryland, United States

Location

#187

Worcester, Massachusetts, United States

Location

#811

Detroit, Michigan, United States

Location

#015

Bellevue, Nebraska, United States

Location

#170

Bellevue, Nebraska, United States

Location

#081

Lincoln, Nebraska, United States

Location

#017

Omaha, Nebraska, United States

Location

#041

Omaha, Nebraska, United States

Location

#169

Omaha, Nebraska, United States

Location

#112

Henderson, Nevada, United States

Location

#146

Henderson, Nevada, United States

Location

#079

Las Vegas, Nevada, United States

Location

#176

Las Vegas, Nevada, United States

Location

#171

Brooklyn, New York, United States

Location

#011

Endwell, New York, United States

Location

#164

New York, New York, United States

Location

#021

Harrisburg, North Carolina, United States

Location

#178

High Point, North Carolina, United States

Location

#189

Morganton, North Carolina, United States

Location

#030

Carlisle, Ohio, United States

Location

#006

Cleveland, Ohio, United States

Location

#182

Grove City, Ohio, United States

Location

#083

Wadsworth, Ohio, United States

Location

#167

Oklahoma City, Oklahoma, United States

Location

#810

Oklahoma City, Oklahoma, United States

Location

#071

Tulsa, Oklahoma, United States

Location

#045

Portland, Oregon, United States

Location

#024

Bridgeville, Pennsylvania, United States

Location

#815

Clairton, Pennsylvania, United States

Location

#192

Harleysville, Pennsylvania, United States

Location

#816

Philladelphia, Pennsylvania, United States

Location

#191

Pittsburgh, Pennsylvania, United States

Location

#828

Scottdale, Pennsylvania, United States

Location

#824

Uniontown, Pennsylvania, United States

Location

#194

Johnston, Rhode Island, United States

Location

#819

Clinton, South Carolina, United States

Location

#805

Easley, South Carolina, United States

Location

#160

Murrells Inlet, South Carolina, United States

Location

#833

Orangeburg, South Carolina, United States

Location

#831

Pawleys Island, South Carolina, United States

Location

#147

Simpsonville, South Carolina, United States

Location

#002

Rapid City, South Dakota, United States

Location

#084

Clarksville, Tennessee, United States

Location

#001

Amarillo, Texas, United States

Location

#812

Arlington, Texas, United States

Location

#137

Austin, Texas, United States

Location

#037

Beaumont, Texas, United States

Location

#113

Bryan, Texas, United States

Location

#058

Carrollton, Texas, United States

Location

#066

Corpus Christi, Texas, United States

Location

#039

Houston, Texas, United States

Location

#053

Houston, Texas, United States

Location

#132

Houston, Texas, United States

Location

#136

Houston, Texas, United States

Location

#157

Houston, Texas, United States

Location

#158

Katy, Texas, United States

Location

#003