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

October 20, 2015 updated by: MDVI, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia
        • #216
      • Burwood, New South Wales, Australia
        • #207
      • Carlton, New South Wales, Australia
        • #214
      • Darlinghurst, New South Wales, Australia
        • #208
      • Glebe, New South Wales, Australia
        • #205
      • Maroubra, New South Wales, Australia
        • #201
      • Neutral Bay, New South Wales, Australia
        • #218
      • Sydney, New South Wales, Australia
        • #202
      • Sydney, New South Wales, Australia
        • #204
    • Queensland
      • Biggera Waters, Queensland, Australia
        • #219
      • Caboolture, Queensland, Australia
        • #215
      • Deception Bay, Queensland, Australia
        • #221
      • Jimboomba, Queensland, Australia
        • #217
      • Nerang, Queensland, Australia
        • #220
      • Sherwood, Queensland, Australia
        • #206
    • Western Australia
      • Mirrabooka, Western Australia, Australia
        • #223
      • Morley, Western Australia, Australia
        • #222
      • Spearwood, Western Australia, Australia
        • #224
  • Chile
      • Antofagasta, Chile
        • #613
      • Curico, Chile
        • #612
      • Quillota, Chile
        • #606
      • Rancagua, Chile
        • #614
      • Santiago, Chile
        • #603
      • Santiago, Chile
        • #607
      • Santiago, Chile
        • #609
      • Santiago, Chile
        • #610
      • Talca, Chile
        • #602
      • Temuco, Chile
        • #600
      • Temuco, Chile
        • #601
      • Viña del Mar, Chile
        • #611
  • New Zealand
      • Auckland, New Zealand
        • #307
      • Hamilton, New Zealand
        • #308
    • Auckland
      • Otara, Auckland, New Zealand
        • #306
    • Bay of Plenty
      • Rotorua, Bay of Plenty, New Zealand
        • #305
      • Tauranga, Bay of Plenty, New Zealand
        • #302
    • Canterbury
      • Christchurch, Canterbury, New Zealand
        • #301
    • Otago
      • Dunedin, Otago, New Zealand
        • #304
  • Paraguay
    • Asuncion
      • Florida, Asuncion, Paraguay
        • #702
      • Pai Perez, Asuncion, Paraguay
        • #707
    • Asunción
      • esquina Pai Perez, Asunción, Paraguay
        • #703
    • Luque
      • Campos Cervera, Luque, Paraguay
        • #704
  • Peru
      • Arequipa, Peru
        • #505
      • Callao, Peru
        • #511
      • Cusco, Peru
        • #506
      • ICA, Peru
        • #513
      • Lima, Peru
        • #500
      • Lima, Peru
        • #501
      • Lima, Peru
        • #502
      • Lima, Peru
        • #504
      • Lima, Peru
        • #508
      • Lima, Peru
        • #509
      • Lima, Peru
        • #510
      • Lima, Peru
        • #512
      • Lima, Peru
        • #515
      • Lima, Peru
        • #516
      • Lima, Peru
        • #517
      • Piura, Peru
        • #514
      • Trujillo, Peru
        • #507
  • South Africa
      • Benoni, South Africa
        • #421
      • Cape Town, South Africa
        • #402
      • Durban, South Africa
        • #405
      • Durban, South Africa
        • #406
      • Durban, South Africa
        • #408
      • Durban, South Africa
        • #412
      • Durban, South Africa
        • #414
      • Johannesburg, South Africa
        • #404
      • Kemptonpark, South Africa
        • #422
      • Kraaifontein, South Africa
        • #411
      • Krugersdorp, South Africa
        • #410
      • Port Elizabeth, South Africa
        • #407
      • Pretoria, South Africa
        • #409
      • Pretoria, South Africa
        • #413
      • Pretoria, South Africa
        • #415
      • Pretoria, South Africa
        • #418
      • Pretoria, South Africa
        • #419
      • Pretoria, South Africa
        • #420
      • Pretoria, South Africa
        • #423
      • Sandton, South Africa
        • #417
      • Somerset West, South Africa
        • #416
      • Soweto, South Africa
        • #401
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • #065
      • Huntsville, Alabama, United States
        • #156
      • Mobile, Alabama, United States
        • #151
      • Scottsboro, Alabama, United States
        • #155
      • Toney, Alabama, United States
        • #173
      • Tuscumbia, Alabama, United States
        • #161
    • Arizona
      • Chandler, Arizona, United States
        • #089
      • Green Valley, Arizona, United States
        • #018
      • Mesa, Arizona, United States
        • #110
      • Phoenix, Arizona, United States
        • #105
      • Tucson, Arizona, United States
        • #188
    • Arkansas
      • Jonesboro, Arkansas, United States
        • #107
      • North Little Rock, Arkansas, United States
        • #019
      • Searcy, Arkansas, United States
        • #140
    • California
      • Anaheim, California, United States
        • #059
      • Anaheim, California, United States
        • #179
      • Chino, California, United States
        • #032
      • Cypress, California, United States
        • #154
      • Garden Grove, California, United States
        • #004
      • Long Beach, California, United States
        • #144
      • Los Angeles, California, United States
        • #043
      • Los Angeles, California, United States
        • #139
      • Oxnard, California, United States
        • #096
      • Pacific Palisades, California, United States
        • #091
      • Pasadena, California, United States
        • #114
      • Pico Rivera, California, United States
        • #111
      • Pomona, California, United States
        • #097
      • Sacramento, California, United States
        • #068
      • San Diego, California, United States
        • #035
      • San Diego, California, United States
        • #054
      • Torrance, California, United States
        • #042
    • Connecticut
      • Bridgeport, Connecticut, United States
        • #197
    • Florida
      • Boca Raton, Florida, United States
        • #022
      • Boynton Beach, Florida, United States
        • #152
      • Coral Gables, Florida, United States
        • #060
      • Delray Beach, Florida, United States
        • #007
      • Edgewater, Florida, United States
        • #086
      • Ft. Myers, Florida, United States
        • #016
      • Gainesville, Florida, United States
        • #038
      • Hialeah, Florida, United States
        • #014
      • Hialeah, Florida, United States
        • #052
      • Hialeah, Florida, United States
        • #088
      • Jacksonville, Florida, United States
        • #035
      • Kissimmee, Florida, United States
        • #094
      • Kissimmee, Florida, United States
        • #153
      • Lauderdale Lakes, Florida, United States
        • #177
      • Melbourne, Florida, United States
        • #012
      • Miami, Florida, United States
        • #034
      • Miami, Florida, United States
        • #040
      • Miami, Florida, United States
        • #047
      • Miami, Florida, United States
        • #082
      • Miami, Florida, United States
        • #166
      • Miami Gardens, Florida, United States
        • #149
      • Pinellas Park, Florida, United States
        • #134
      • Port Orange, Florida, United States
        • #050
      • Venice, Florida, United States
        • #163
      • West Palm Beach, Florida, United States
        • #020
    • Georgia
      • Snellville, Georgia, United States
        • #814
    • Hawaii
      • Honolulu, Hawaii, United States
        • #080
    • Idaho
      • Boise, Idaho, United States
        • #063
    • Illinois
      • Oak Lawn, Illinois, United States
        • #835
    • Indiana
      • Fishers, Indiana, United States
        • #804
      • Franklin, Indiana, United States
        • #803
      • Greenfield, Indiana, United States
        • #198
      • Munci, Indiana, United States
        • #195
    • Iowa
      • Council Bluffs, Iowa, United States
        • #168
      • West Des Moines, Iowa, United States
        • #827
    • Kansas
      • Newton, Kansas, United States
        • #008
      • Shawnee, Kansas, United States
        • #138
      • Wichita, Kansas, United States
        • #106
    • Kentucky
      • Hazard, Kentucky, United States
        • #055
    • Louisiana
      • Alexandria, Louisiana, United States
        • #823
      • Baton Rouge, Louisiana, United States
        • #801
    • Maryland
      • Elkridge, Maryland, United States
        • #048
      • Silver Spring, Maryland, United States
        • #085
    • Massachusetts
      • Worcester, Massachusetts, United States
        • #187
    • Michigan
      • Detroit, Michigan, United States
        • #811
    • Nebraska
      • Bellevue, Nebraska, United States
        • #015
      • Bellevue, Nebraska, United States
        • #170
      • Lincoln, Nebraska, United States
        • #081
      • Omaha, Nebraska, United States
        • #017
      • Omaha, Nebraska, United States
        • #041
      • Omaha, Nebraska, United States
        • #169
    • Nevada
      • Henderson, Nevada, United States
        • #112
      • Henderson, Nevada, United States
        • #146
      • Las Vegas, Nevada, United States
        • #079
      • Las Vegas, Nevada, United States
        • #176
    • New York
      • Brooklyn, New York, United States
        • #171
      • Endwell, New York, United States
        • #011
      • New York, New York, United States
        • #164
    • North Carolina
      • Harrisburg, North Carolina, United States
        • #021
      • High Point, North Carolina, United States
        • #178
      • Morganton, North Carolina, United States
        • #189
    • Ohio
      • Carlisle, Ohio, United States
        • #030
      • Cleveland, Ohio, United States
        • #006
      • Grove City, Ohio, United States
        • #182
      • Wadsworth, Ohio, United States
        • #083
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • #167
      • Oklahoma City, Oklahoma, United States
        • #810
      • Tulsa, Oklahoma, United States
        • #071
    • Oregon
      • Portland, Oregon, United States
        • #045
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States
        • #024
      • Clairton, Pennsylvania, United States
        • #815
      • Harleysville, Pennsylvania, United States
        • #192
      • Philladelphia, Pennsylvania, United States
        • #816
      • Pittsburgh, Pennsylvania, United States
        • #191
      • Scottdale, Pennsylvania, United States
        • #828
      • Uniontown, Pennsylvania, United States
        • #824
    • Rhode Island
      • Johnston, Rhode Island, United States
        • #194
    • South Carolina
      • Clinton, South Carolina, United States
        • #819
      • Easley, South Carolina, United States
        • #805
      • Murrells Inlet, South Carolina, United States
        • #160
      • Orangeburg, South Carolina, United States
        • #833
      • Pawleys Island, South Carolina, United States
        • #831
      • Simpsonville, South Carolina, United States
        • #147
    • South Dakota
      • Rapid City, South Dakota, United States
        • #002
    • Tennessee
      • Clarksville, Tennessee, United States
        • #084
    • Texas
      • Amarillo, Texas, United States
        • #001
      • Arlington, Texas, United States
        • #812
      • Austin, Texas, United States
        • #137
      • Beaumont, Texas, United States
        • #037
      • Bryan, Texas, United States
        • #113
      • Carrollton, Texas, United States
        • #058
      • Corpus Christi, Texas, United States
        • #066
      • Houston, Texas, United States
        • #039
      • Houston, Texas, United States
        • #053
      • Houston, Texas, United States
        • #132
      • Houston, Texas, United States
        • #136
      • Houston, Texas, United States
        • #157
      • Katy, Texas, United States
        • #158
      • San Antonio, Texas, United States
        • #003
      • San Antonio, Texas, United States
        • #108
      • San Antonio, Texas, United States
        • #180
      • San Antonio, Texas, United States
        • #817
      • San Antonio, Texas, United States
        • #818
      • Sugar Land, Texas, United States
        • #830
      • Tomball, Texas, United States
        • #135
      • Tomball, Texas, United States
        • #809
    • Utah
      • Draper, Utah, United States
        • #822
      • Orem, Utah, United States
        • #090
      • Salt Lake City, Utah, United States
        • #117
      • Salt Lake City, Utah, United States
        • #832
      • South Jordan, Utah, United States
        • #825
      • West Jordan, Utah, United States
        • #133
    • Virginia
      • Alexandria, Virginia, United States
        • #142
      • Alexandria, Virginia, United States
        • #800
      • Richmond, Virginia, United States
        • #009
    • Washington
      • Spokane, Washington, United States
        • #172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo comparator
Placebo BID x 1 day, and Placebo BID x 4 days
EXPERIMENTAL: 1: 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
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
Drug: Favipiravir
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
EXPERIMENTAL: 2: Experimental
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Drug: Favipiravir
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
Drug: Favipiravir
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
Time Frame: 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.
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MDVI, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Macy Guiont, Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T705aUS204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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