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

NCT ID: NCT01068912

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-05-31

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).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1: Experimental

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

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

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

2: Experimental

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

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

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

Interventions

Favipiravir

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

Intervention Type: DRUG

Favipiravir

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

Intervention Type: DRUG

Placebo comparator

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

Intervention Type: DRUG

Eligibility Criteria

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)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MDVI, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Macy Guiont

Role: STUDY_DIRECTOR

Syneos Health

Locations

#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

#188

Tucson, Arizona, United States

#107

Jonesboro, Arkansas, United States

#019

North Little Rock, Arkansas, United States

#140

Searcy, Arkansas, United States

#059

Anaheim, California, United States

#179

Anaheim, California, United States

#032

Chino, California, United States

#154

Cypress, California, United States

#004

Garden Grove, California, United States

#144

Long Beach, California, United States

#043

Los Angeles, California, United States

#139

Los Angeles, California, United States

#096

Oxnard, California, United States

#091

Pacific Palisades, California, United States

#114

Pasadena, California, United States

#111

Pico Rivera, California, United States

#097

Pomona, California, United States

#068

Sacramento, California, United States

#035

San Diego, California, United States

#054

San Diego, California, United States

#042

Torrance, California, United States

#197

Bridgeport, Connecticut, United States

#022

Boca Raton, Florida, United States

#152

Boynton Beach, Florida, United States

#060

Coral Gables, Florida, United States

#007

Delray Beach, Florida, United States

#086

Edgewater, Florida, United States

#016

Fort Myers, Florida, United States

#038

Gainesville, Florida, United States

#014

Hialeah, Florida, United States

#052

Hialeah, Florida, United States

#088

Hialeah, Florida, United States

#035

Jacksonville, Florida, United States

#094

Kissimmee, Florida, United States

#153

Kissimmee, Florida, United States

#177

Lauderdale Lakes, Florida, United States

#012

Melbourne, 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, Florida, United States

#149

Miami Gardens, Florida, United States

#134

Pinellas Park, Florida, United States

#050

Port Orange, Florida, United States

#163

Venice, Florida, United States

#020

West Palm Beach, Florida, United States

#814

Snellville, Georgia, United States

#080

Honolulu, Hawaii, United States

#063

Boise, Idaho, United States

#835

Oak Lawn, Illinois, United States

#804

Fishers, Indiana, United States

#803

Franklin, Indiana, United States

#198

Greenfield, Indiana, United States

#195

Munci, Indiana, United States

#168

Council Bluffs, Iowa, United States

#827

West Des Moines, Iowa, United States

#008

Newton, Kansas, United States

#138

Shawnee, Kansas, United States

#106

Wichita, Kansas, United States

#055

Hazard, Kentucky, United States

#823

Alexandria, Louisiana, United States

#801

Baton Rouge, Louisiana, United States

#048

Elkridge, Maryland, United States

#085

Silver Spring, Maryland, United States

#187

Worcester, Massachusetts, United States

#811

Detroit, Michigan, United States

#015

Bellevue, Nebraska, United States

#170

Bellevue, Nebraska, United States

#081

Lincoln, Nebraska, United States

#017

Omaha, Nebraska, United States

#041

Omaha, Nebraska, United States

#169

Omaha, Nebraska, United States

#112

Henderson, Nevada, United States

#146

Henderson, Nevada, United States

#079

Las Vegas, Nevada, United States

#176

Las Vegas, Nevada, United States

#171

Brooklyn, New York, United States

#011

Endwell, New York, United States

#164

New York, New York, United States

#021

Harrisburg, North Carolina, United States

#178

High Point, North Carolina, United States

#189

Morganton, North Carolina, United States

#030

Carlisle, Ohio, United States

#006

Cleveland, Ohio, United States

#182

Grove City, Ohio, United States

#083

Wadsworth, Ohio, United States

#167

Oklahoma City, Oklahoma, United States

#810

Oklahoma City, Oklahoma, United States

#071

Tulsa, Oklahoma, United States

#045

Portland, Oregon, United States

#024

Bridgeville, Pennsylvania, United States

#815

Clairton, Pennsylvania, United States

#192

Harleysville, Pennsylvania, United States

#816

Philladelphia, Pennsylvania, United States

#191

Pittsburgh, Pennsylvania, United States

#828

Scottdale, Pennsylvania, United States

#824

Uniontown, Pennsylvania, United States

#194

Johnston, Rhode Island, United States

#819

Clinton, South Carolina, United States

#805

Easley, South Carolina, United States

#160

Murrells Inlet, South Carolina, United States

#833

Orangeburg, South Carolina, United States

#831

Pawleys Island, South Carolina, United States

#147

Simpsonville, South Carolina, United States

#002

Rapid City, South Dakota, United States

#084

Clarksville, Tennessee, United States

#001

Amarillo, Texas, United States

#812

Arlington, Texas, United States

#137

Austin, Texas, United States

#037

Beaumont, Texas, United States

#113

Bryan, Texas, United States

#058

Carrollton, Texas, United States

#066

Corpus Christi, Texas, United States

#039

Houston, Texas, United States

#053

Houston, Texas, United States

#132

Houston, Texas, United States

#136

Houston, Texas, United States

#157

Houston, Texas, United States

#158

Katy, 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

San Antonio, Texas, United States

#830

Sugar Land, Texas, United States

#135

Tomball, Texas, United States

#809

Tomball, Texas, United States

#822

Draper, Utah, United States

#090

Orem, Utah, United States

#117

Salt Lake City, Utah, United States

#832

Salt Lake City, Utah, United States

#825

South Jordan, Utah, United States

#133

West Jordan, Utah, United States

#142

Alexandria, Virginia, United States

#800

Alexandria, Virginia, United States

#009

Richmond, Virginia, United States

#172

Spokane, Washington, United States

#216

Blacktown, New South Wales, Australia

#207

Burwood, New South Wales, Australia

#214

Carlton, New South Wales, Australia

#208

Darlinghurst, New South Wales, Australia

#205

Glebe, New South Wales, Australia

#201

Maroubra, New South Wales, Australia

#218

Neutral Bay, New South Wales, Australia

#202

Sydney, New South Wales, Australia

#204

Sydney, New South Wales, Australia

#219

Biggera Waters, Queensland, Australia

#215

Caboolture, Queensland, Australia

#221

Deception Bay, Queensland, Australia

#217

Jimboomba, Queensland, Australia

#220

Nerang, Queensland, Australia

#206

Sherwood, Queensland, Australia

#223

Mirrabooka, Western Australia, Australia

#222

Morley, Western Australia, Australia

#224

Spearwood, Western Australia, Australia

#613

Antofagasta, , Chile

#612

Curicó, , Chile

#606

Quillota, , Chile

#614

Rancagua, , Chile

#603

Santiago, , Chile

#607

Santiago, , Chile

#609

Santiago, , Chile

#610

Santiago, , Chile

#602

Talca, , Chile

#600

Temuco, , Chile

#601

Temuco, , Chile

#611

Viña del Mar, , Chile

#306

Otara, Auckland, New Zealand

#305

Rotorua, Bay of Plenty, New Zealand

#302

Tauranga, Bay of Plenty, New Zealand

#301

Christchurch, Canterbury, New Zealand

#304

Dunedin, Otago, New Zealand

#307

Auckland, , New Zealand

#308

Hamilton, , New Zealand

#703

Esquina Pai Perez, Asunción, Paraguay

#702

Florida, Asunción, Paraguay

#707

Pai Perez, Asunción, Paraguay

#704

Campos Cervera, Luque, Paraguay

#505

Arequipa, , Peru

#511

Callao, , Peru

#506

Cusco, , Peru

#513

Ica, , 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

Lima, , Peru

#514

Piura, , Peru

#507

Trujillo, , Peru

#421

Benoni, , South Africa

#402

Cape Town, , South Africa

#405

Durban, , South Africa

#406

Durban, , South Africa

#408

Durban, , South Africa

#412

Durban, , South Africa

#414

Durban, , South Africa

#404

Johannesburg, , South Africa

#422

Kempton Park, , South Africa

#411

Kraaifontein, , South Africa

#410

Krugersdorp, , South Africa

#407

Port Elizabeth, , 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

Pretoria, , South Africa

#417

Sandton, , South Africa

#416

Somerset West, , South Africa

#401

Soweto, , South Africa

Countries

United States; Australia; Chile; New Zealand; Paraguay; Peru; South Africa

References

Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.

Reference Type: DERIVED

PMID: 37739792 (View on PubMed)

Other Identifiers

T705aUS204

Identifier Type: -

Identifier Source: org_study_id