Last updated on July 2019

A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent Adult and Elderly Hospitalized Participants With Influenza A Infection


Brief description of study

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

Detailed Study Description

This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.

Clinical Study Identifier: NCT03376321

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Nea Baptist Clinic

Jonesboro, AR United States
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UCSF Fresno

Fresno, CA United States
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PAB Clinical Research

Brandon, FL United States
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University of Florida

Gainesville, FL United States
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Miami Clinical Research

Miami, FL United States
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Destin Pulmonary Critical Care, PLLS.

Santa Rosa Beach, FL United States
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Augusta University

Augusta, GA United States
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Northwestern University

Chicago, IL United States
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Henry Ford Hospital

Detroit, MI United States
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Wayne State University

Detroit, MI United States
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William Beaumont Hospital

Royal Oak, MI United States
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Washington University

Saint Louis, MO United States
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Holy Name Medical Center

Teaneck, NJ United States
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Remington-Davis, Inc

Columbus, OH United States
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Lowcountry Infectious Diseases

Charleston, SC United States
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CliniCore Houston

Houston, TX United States
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DM Clinical Research

Tomball, TX United States
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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Hospital Posadas

El Palomar, Argentina
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Sanatorio Juan XXIII

General Roca, Argentina
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Hospital Italiano de La Plata

La Plata Lpl Lpl, Argentina
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Flinders Medical Centre

Bedford Park, Australia
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Box Hill Hospital

Box Hill, Australia
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The Alfred Hospital

Melbourne, Australia
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Mater Hospital Brisbane

South Brisbane, Australia
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Townsville Hospital

Townsville, Australia
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Westmead Hospital

Westmead, Australia
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CHU Saint-Pierre

Bruxelles, Belgium
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Hospital da Luz

Sao Paulo, Brazil
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MHAT Dr Stefan Cherkezov

Veliko Tarnovo, Bulgaria
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Hospital El Pino

San Bernardo, Chile
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Fakultni nemocnice Ostrava

Ostrava - Poruba, Czechia
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Nemocnice Na Bulovce

Praha 8 - Libe?, Czechia
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CHU Dijon

Dijon, France
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Centre Hospitalier D partemental

La Roche S/ Yon Cedex 9, France
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H pital Nord - Marseille

Marseille cedex 20, France
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CHU Nantes - Hotel Dieu

NANTES Cedex 01, France
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Hopital Saint-Louis

Paris cedex 10, France
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CHU Saint-Etienne - H pital Nord

Saint-Etienne Cedex 2, France
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Korea University Ansan Hospital

Ansan-si, Korea, Republic of
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Dong-A University Hospital

Pusan, Korea, Republic of
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Asan Medical Center

Seoul, Korea, Republic of
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Hospital Selayang

Batu Caves, Malaysia
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Hospital Queen Elizabeth

Kota Kinabalu, Malaysia
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Hospital Sungai Buloh

Sungai Buloh, Malaysia
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JM Research, SC

Cuernavaca, Mexico
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Jeroen Bosch Ziekenhuis

s-Hertogenbosch, Netherlands
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UMC Utrecht

Utrecht, Netherlands
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Christchurch Hospital

Christchurch, New Zealand
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Waikato Hospital

Hamilton, New Zealand
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Rotorua Hospital

Rotorua, New Zealand
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Tauranga Hospital

Tauranga, New Zealand
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Wellington Hospital

Wellington, New Zealand
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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Northside Hospital

Atlanta, GA United States
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Anne Arundel Medical Center

Annapolis, MD United States
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UC Health LLC

Cincinnati, OH United States
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Rhode Island Hospital

Providence, RI United States
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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Hospital Rawson

Córdoba, Argentina
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Hospital San Roque

Córdoba, Argentina
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Hospital Cordoba

Córdoba, Argentina
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H pital Nord - Marseille

Marseille Cedex 20, France
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CHU Nantes - Hotel Dieu

Nantes Cedex 01, France
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Hopital Saint-Louis

Paris Cedex 10, France
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Clinical Hospital #3

Yaroslavl, Russian Federation
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DFNsP Bratislava

Bratislava, Slovakia
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Johese Unitas

Centurion, South Africa
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Abdullah, IA

Durban, South Africa
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Sebastian, Peter

Durban, South Africa
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DJW Research

Krugersdorp, South Africa
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Emmed Research

Pretoria, South Africa
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Into Research

Pretoria, South Africa
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Hosp. Univ. Donostia

Donostia-San Sebastian, Spain
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Hosp. Clinico Univ. de Santiago

Santiago De Compostela, Spain
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Korea University Ansan Hospital

Ansan-Si, Korea, Republic of
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Recruitment Status: Open


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