A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications

NCT ID: NCT03381196

Last Updated: 2025-02-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-21

Study Completion Date

2020-08-24

Brief Summary

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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 Description

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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 (13 to 17 years), adult (18 to 65 years), and elderly (greater than \[\>\] 65 but less than or equal to \[\<=\] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.

Conditions

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Influenza A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Arm 1 (pimodivir + SOC treatment)

Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).

Group Type EXPERIMENTAL

Pimodivir 600 mg

Intervention Type DRUG

Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6).

SOC Treatment

Intervention Type OTHER

Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).

Treatment Arm 2 (placebo + SOC treatment)

Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6).

SOC Treatment

Intervention Type OTHER

Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).

Interventions

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Pimodivir 600 mg

Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6).

Intervention Type DRUG

Placebo

Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6).

Intervention Type DRUG

SOC Treatment

Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).

Intervention Type OTHER

Other Intervention Names

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JNJ-63623872

Eligibility Criteria

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Inclusion Criteria

* Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
* Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
* Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (\<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
* Enrollment and initiation of study drug treatment less than or equal to (\<=)72 hours after onset of influenza symptoms
* Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease \[COPD\] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus \[HIV\], cancer, or chronic liver or kidney disease \[presence of kidney damage for \>3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests\], or participants taking chronic systemic steroids)

Exclusion Criteria

* Received more than (\>)1 dose of influenza antiviral medication (for example, oseltamivir \[OST\] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir \>1 day prior to screening
* Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
* Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
* Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
* Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus \[CD4+\] count \<200 cells per cubic millimeter \[cells/mm\^3\], absolute neutrophil count \<750/mm\^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)
Minimum Eligible Age

13 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

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Cahaba Research Inc

Birmingham, Alabama, United States

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Scottsboro Quick Care Clinic

Scottsboro, Alabama, United States

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SC Clinical Research Inc.

California City, California, United States

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Research Center of Fresno Inc

Fresno, California, United States

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Allied Clinical Research

Gold River, California, United States

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Innovative Clinical Research Inc

Harbor City, California, United States

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Om Research LLC

Lancaster, California, United States

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Ark Clinical Research

Long Beach, California, United States

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Miller Children's Hospital

Long Beach, California, United States

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Downtown LA Research Center, Inc

Los Angeles, California, United States

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California Allergy & Asthma Medical Group Inc.

Los Angeles, California, United States

Site Status

Adam D. Karns, MD

Los Angeles, California, United States

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Lucita M. Cruz Md Inc

Norwalk, California, United States

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Asclepes Research

Panorama City, California, United States

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Center for Clinical Trials LLC

Paramount, California, United States

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Benchmark Research

Sacramento, California, United States

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Medical Associates Research Group, Inc.

San Diego, California, United States

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San Diego Sports Medicine & Family Health Center

San Diego, California, United States

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West Coast Clinical Research, LLC

San Ramon, California, United States

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Stanford University

Stanford, California, United States

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Lynn Institute

Colorado Springs, Colorado, United States

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Complete Family Care

Northglenn, Colorado, United States

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Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado, United States

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Chase Medical Research, LLC

Waterbury, Connecticut, United States

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Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

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Moonshine Research Center, Inc

Doral, Florida, United States

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Best Quality Research Inc

Hialeah, Florida, United States

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Floridian Clinical Research LLC

Hialeah, Florida, United States

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The community Research of South Florida

Hialeah, Florida, United States

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Encore Medical Research, LLC

Hollywood, Florida, United States

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Homestead Associates in Research Inc

Homestead, Florida, United States

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Care Partners Clinical Research

Jacksonville, Florida, United States

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Premier Medical Group

Lady Lake, Florida, United States

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Sima Research Clinic

Miami, Florida, United States

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Universal Clinical Research Associates

Miami, Florida, United States

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South Florida Research Center Inc.

Miami, Florida, United States

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A Plus Research

Miami, Florida, United States

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Nuren Medical & Research Center

Miami, Florida, United States

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Coral Research Clinic Corp

Miami, Florida, United States

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New Horizon Research Center

Miami, Florida, United States

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Vista Health Research, LLC

Miami, Florida, United States

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Crystal Biomedical Research

Miami Lakes, Florida, United States

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Combined Research Orlando

Orlando, Florida, United States

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Clinical NeuroScience Solutions Inc

Orlando, Florida, United States

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Omega Research Consultants

Orlando, Florida, United States

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Pines Care Research Center Inc

Pembroke Pines, Florida, United States

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South Broward Research, LLC

Pembroke Pines, Florida, United States

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Destin Pulmonary Critical Care, PLLS.

Santa Rosa Beach, Florida, United States

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Vita Health and Medical center

Tamarac, Florida, United States

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Asclepes Research

Weeki Wachee, Florida, United States

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Axcess Medical Research, LLC

Wellington, Florida, United States

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Cozy Research, Llc

Zephyrhills, Florida, United States

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Snake River Research, PLLC

Idaho Falls, Idaho, United States

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Saltzer Medical Group

Nampa, Idaho, United States

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

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Investigators Research Group, LLC

Brownsburg, Indiana, United States

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Medisphere Medical Research Center, Llc

Evansville, Indiana, United States

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Hutchinson Clinic

Hutchinson, Kansas, United States

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The Research Group of Lexington, LLC

Lexington, Kentucky, United States

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Clinical Trials Management, LLC

Metairie, Louisiana, United States

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Medpharmics, LLC

Metairie, Louisiana, United States

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North Star Clinical Research, LLC

Shreveport, Louisiana, United States

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University Of Maryland Medical Center

Baltimore, Maryland, United States

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Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

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Centennial Medical Group

Elkridge, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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Wayne State Univ School of Medicine

Detroit, Michigan, United States

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Wayne State University

Detroit, Michigan, United States

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William Beaumont Hospital

Royal Oak, Michigan, United States

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Tri County Research, Inc.

Sterling Heights, Michigan, United States

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William Beaumont Hospital

Troy, Michigan, United States

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Arcturus Healthcare PLC

Troy, Michigan, United States

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Craig A. Spiegel, MD

Bridgeton, Missouri, United States

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Mercury Street Medical Group, PLLC

Butte, Montana, United States

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Montana Medical Research

Missoula, Montana, United States

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Barrett Clinic P.C.

La Vista, Nebraska, United States

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Nebraska Medical Center

Omaha, Nebraska, United States

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Next Phase Research Alliance

Las Vegas, Nevada, United States

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Saint Michaels Medical Center

Newark, New Jersey, United States

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Accellacare Research of Cary

Cary, North Carolina, United States

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Onsite Clinical Solutions

Clemmons, North Carolina, United States

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Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

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clinical research of Gastonia

Gastonia, North Carolina, United States

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Hickory Research Center.

Hickory, North Carolina, United States

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Monroe Biomedical Research

Monroe, North Carolina, United States

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Burke Primary Care

Morganton, North Carolina, United States

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PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, United States

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PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

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Clinical Trials of America

Winston-Salem, North Carolina, United States

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Southeastern Research Center LLC

Winston-Salem, North Carolina, United States

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Dayton Clinical Research

Dayton, Ohio, United States

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Buckeye Health and Research, LLC

Hilliard, Ohio, United States

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Lancaster General Hospital

Lancaster, Pennsylvania, United States

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Detweiler Family Medicine and Associates

Lansdale, Pennsylvania, United States

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Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

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Preferred Primary Care Physicians Research

Pittsburgh, Pennsylvania, United States

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Frontier Clinical Research

Smithfield, Pennsylvania, United States

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Preferred Primary Care Physicians Research

Uniontown, Pennsylvania, United States

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AAPRI Clinical Research Institute

Warwick, Rhode Island, United States

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Spectrum Medical Research

Gaffney, South Carolina, United States

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DeGarmo Institute of Medical Research

Greer, South Carolina, United States

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PMG Research of Charleston, LLC

Mt. Pleasant, South Carolina, United States

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Fusion Clinical Research of Spartanburg

Spartanburg, South Carolina, United States

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Invocare Clinical Research Center

West Columbia, South Carolina, United States

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Health Concepts

Rapid City, South Dakota, United States

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PMG Research of Bristol

Bristol, Tennessee, United States

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PMG Research of Knoxville

Jefferson City, Tennessee, United States

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PMG Research of Knoxville

Knoxville, Tennessee, United States

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HIRG, LLC dba Health Innovation Research Group

Arlington, Texas, United States

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ACRC Trials

Austin, Texas, United States

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Family Medicine Associates of Texas

Carrollton, Texas, United States

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

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WR-Global Medical Research, LLC

DeSoto, Texas, United States

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University Of Texas Medical Branch At Galveston

Galveston, Texas, United States

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San Gabriel Clinical Research, LLC

Georgetown, Texas, United States

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BI Research Center

Houston, Texas, United States

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West Houston Clinical Research Service

Houston, Texas, United States

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Northwest Med Care,P.A.

Houston, Texas, United States

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Southwest Clinical Trials

Houston, Texas, United States

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Dairy Ashford Family Practice

Houston, Texas, United States

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JM Research.PLLC

Houston, Texas, United States

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PCP for Life

Houston, Texas, United States

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SMS Clinical Research LLC

Mesquite, Texas, United States

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Village Health Partners

Plano, Texas, United States

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Tekton Research Inc.

San Antonio, Texas, United States

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DM Clinical Research

San Antonio, Texas, United States

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Renovatio Clinical

The Woodlands, Texas, United States

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ClinPoint Trials

Waxahachie, Texas, United States

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Val Hansen

Bountiful, Utah, United States

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Ericksen Research and Development

Clinton, Utah, United States

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J. Lewis research Inc./ Foothill Family Clinic South

Draper, Utah, United States

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Advanced Research Institute

Ogden, Utah, United States

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Granger Medical Clinic-Riverton

Riverton, Utah, United States

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J. Lewis research Inc./ Foothill Family Care

Salt Lake City, Utah, United States

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J. Lewis research Inc./ Foothill Family Clinic South

Salt Lake City, Utah, United States

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J. Lewis Research Inc/ FirstMed East

Salt Lake City, Utah, United States

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J. Lewis Research Inc./Jordan River Family Medicine

South Jordan, Utah, United States

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Millennium Clinical Trials LLC

Arlington, Virginia, United States

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Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, , Argentina

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CEMIC Saavedra

Ciudad de Buenos Aires, , Argentina

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Hospital Nuestra Señora de la Misericordia

Córdoba, , Argentina

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Hospital Rawson

Córdoba, , Argentina

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Hospital San Roque

Córdoba, , Argentina

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Sanatorio Allende

Córdoba, , Argentina

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Hospital Cordoba

Córdoba, , Argentina

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Hospital Privado Centro Medico de Cordoba

Córdoba, , Argentina

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Sanatorio Juan XXIII

General Roca, , Argentina

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Sanatorio del Oeste Ituzaingo

Ituzaingó, , Argentina

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Instituto Medico Platense

La Plata, , Argentina

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Hospital Italiano de La Plata

La Plata Lpl Lpl, , Argentina

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Sanatorio Britanico S.A.

Rosario, , Argentina

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Instituto Del Buen Aire

Santa Fe, , Argentina

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Northside Health

Coffs Harbour, , Australia

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Mater Hospital Brisbane

South Brisbane, , Australia

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AKH - Medizinische Universitat Wien

Vienna, , Austria

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SMZ Süd - Kaiser Franz Josef Spital Wien

Vienna, , Austria

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CHU Saint-Pierre

Brussels, , Belgium

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Hopital Erasme

Brussels, , Belgium

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Institut Jules Bordet

Brussels, , Belgium

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De Meulemeester, Marc

Gozée, , Belgium

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Jaak Mortelmans

Ham, , Belgium

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Quartier du Furgy 4

Herbeumont, , Belgium

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Research Link

Linkebeek, , Belgium

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BVBA Dr. Luc Capiau

Massemen, , Belgium

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Testumed

Tessenderlo, , Belgium

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Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, , Brazil

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Infection Control Ltda

Brasil, , Brazil

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Hrpc Ulbratech - Ulbra

Canoas, , Brazil

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Centro de Estudos Clínicos do Interior Paulista - CECIP

Jaú, , Brazil

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CMIP - Centro Mineiro de Pesquisa Ltda

Juiz de Fora, , Brazil

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Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

Passo Fundo, , Brazil

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Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

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Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

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CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

Rio de Janeiro, , Brazil

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Pesquisare Saude

Santo André, , Brazil

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CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, , Brazil

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Irmandade Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

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Fundacao Jose Luiz Egydio Setubal

São Paulo, , Brazil

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SHATPPD - Ruse Ltd.

Rousse, , Bulgaria

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MHAT Knyaginya Klementina

Sofia, , Bulgaria

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MHAT 'Lyulin' EAD

Sofia, , Bulgaria

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Acibadem City Clinic Tokuda Hospital

Sofia, , Bulgaria

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DCC II- Sofia EOOD

Sofia, , Bulgaria

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Medical Center 'N. I. Pirogov', EOOD

Sofia, , Bulgaria

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Medical Center Excelsior OOD

Sofia, , Bulgaria

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Military Medical Academy - Sofia

Sofia, , Bulgaria

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MHAT Dr Stefan Cherkezov

Veliko Tarnovo, , Bulgaria

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MC 'Sv. Ivan Rilski', OOD

Vidin, , Bulgaria

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The Bailey Clinic

Red Deer, Alberta, Canada

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Commonwealth Medical Clinic

Mount Pearl, Newfoundland and Labrador, Canada

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Aggarwal and associates Ltd

Brampton, Ontario, Canada

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SKDS Research Inc.

Newmarket, Ontario, Canada

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Bluewater Clinical Research Group Inc.

Sarnia, Ontario, Canada

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Dr. Anil K Gupta Medicine Professional Corporation

Toronto, Ontario, Canada

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Recherche Clinique Sigma Inc.

Québec, Quebec, Canada

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Hospital El Pino

San Bernardo, , Chile

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Centro de Investigacion del Maule

Talca, , Chile

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Hospital de Niños y Cunas

Viña, , Chile

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Chinese PLA General Hospital

Beijing, , China

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Fuzhou General Hospital of Nanjing Military Command

Fuzhou, , China

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The First Affiliated Hospital of NanChang University

Nanchang, , China

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Wuxi People s Hospital

Wuxi, , China

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Henan Provincial Peoples Hospital

Zhengzhou, , China

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ADMED s.r.o.

České Budějovice, , Czechia

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Sanare, s.r.o.

České Budějovice, , Czechia

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Nemocnice Kyjov, p.o.

Kyjov, , Czechia

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Praktik Pb s.r.o

Příbram, , Czechia

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SARKAMED s.r.o.

Slaný, , Czechia

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Prakticky lekar

Sokolov, , Czechia

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Private GP Ilme Last

Paide, , Estonia

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Vee Family Doctor's Center OY

Paide, , Estonia

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OU Innomedica

Tallinn, , Estonia

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Merelahe Family Doctors Center

Tallinn, , Estonia

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Pirita Family Doctors Centre

Tallinn, , Estonia

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Family Doctors Pullerits & Gavronski

Tartu, , Estonia

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Centre Hospitalier d'Agen

Agen, , France

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Centre Hospitalier Intercommunal de Créteil

Créteil, , France

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Centre Hospitalier Départemental

La Roche S/ Yon Cedex 9, , France

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CHU de Grenoble Hopital Albert Michallon

La Tronche, , France

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CHU Nantes - Hotel Dieu

Nantes, , France

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CHU De Nice Hopital De l'Archet

Nice, , France

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Hôpital Bichat - Claude Bernard

Paris, , France

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Hopital Cochin

Paris, , France

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Universitaetsklinikum Koelnt

Cologne, , Germany

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MECS GmbH Cottbus

Cottbus, , Germany

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Jung, Thomas

Deggingen, , Germany

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Universitaetsklinik Erlangen

Erlangen, , Germany

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Universitaetsklinikum Giessen und Marburg GmbH

Giessen, , Germany

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Gemeinschaftspraxis Dr. Klein/ Minnich

Künzing, , Germany

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Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

Leipzig, , Germany

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DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, , Hungary

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Clinexpert Kft

Budapest, , Hungary

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Obudai Egeszsegugyi Centrum Kft

Budapest, , Hungary

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Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

Budapest, , Hungary

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Strázsahegy Medicina Bt

Budapest, , Hungary

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Pestszentimrei Gyermekrendelő

Budapest, , Hungary

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Bugat Pal Korhaz

Gyöngyös, , Hungary

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Futurenest Klinikai Kutato Kft.

Miskolc, , Hungary

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Mohacsi Korhaz

Mohács, , Hungary

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Borbanya Praxis Eu. Kft.

Nyíregyháza, , Hungary

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Medifarma-98 Kft.

Nyíregyháza, , Hungary

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DRC Szentendre

Szentendre, , Hungary

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Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

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DRC Zamardi

Zamárdi, , Hungary

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DRC Zirc

Zirc, , Hungary

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Rajiv Gandhi Institute of Medical Sciences

Balaga, , India

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M S Ramaiah Memorial Hospital

Bangalore, , India

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S. R. Kalla Memorial General Hospital

Jaipur, , India

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Midland Healthcare & Research Center

Lucknow, , India

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Kasturba Medical College Hospital

Manipal, , India

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Suretech Hospital and Research Centre Limited

Nagpur, , India

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Siddhi Hospital

Nashik, , India

Site Status

BLK Super Specialty Hospital

New Delhi, , India

Site Status

Sir Ganga Ram Hospital

New Delhi, , India

Site Status

Sahyadri Speciality Hospital

Pune, , India

Site Status

Lifepoint Multispecialty Hospital

Pune, , India

Site Status

Shree Giriraj Multispeciality Hospital

Rajkot, , India

Site Status

Unique Hospital

Surat, , India

Site Status

BAPS Pramukhswami Hospital

Surat, , India

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Bnai Zion Medical Center

Haifa, , Israel

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Galilee Medical Center

Nahariya, , Israel

Site Status

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Ziv Medical Center

Safed, , Israel

Site Status

ASST Grande Ospedale Metropolitano Niguarda

Milan, , Italy

Site Status

AOU Policlinico di Modena

Modena, , Italy

Site Status

Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

Monza, , Italy

Site Status

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status

Liga Kozlovska family doctor practice

Balvi, , Latvia

Site Status

OLVI Medical Centre

Daugavpils, , Latvia

Site Status

Baiba Bake GP practice

Jelgava, , Latvia

Site Status

Ruta Eglite's Private Practice

Kuldīga, , Latvia

Site Status

Inese Cebere GP practice

Liepāja, , Latvia

Site Status

S. Boreiko Doctor's Practice

Ogre, , Latvia

Site Status

Children's Clinical University Hospital

Riga, , Latvia

Site Status

Clinic of GP A.Lasmanis 'ALMA'

Riga, , Latvia

Site Status

Health Centre 4

Riga, , Latvia

Site Status

Inese Petrova General Practitioner Practice

Tukums, , Latvia

Site Status

Medical Practice BINI

Ventspils, , Latvia

Site Status

Auki Sveikas

Kaunas, , Lithuania

Site Status

Silainiai Family Health Center, JSC

Kaunas, , Lithuania

Site Status

Saules Seimos Medicinos Centras, JSC

Kaunas, , Lithuania

Site Status

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Site Status

Siauliai Republican Hospital, Public Institution

Šiauliai, , Lithuania

Site Status

Inlita, JSC, Lazdynai KTC clinical trial site

Vilnius, , Lithuania

Site Status

Central Outpatient Clinic

Vilnius, , Lithuania

Site Status

Inlita, JSC

Vilnius, , Lithuania

Site Status

Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, , Lithuania

Site Status

Klinik Kesihatan Cheras Baru

Cheras Baru, , Malaysia

Site Status

Klinik Kesihatan Kuang

Kuang, , Malaysia

Site Status

Hospital Miri

Miri, , Malaysia

Site Status

Hospital Taiping

Taiping, , Malaysia

Site Status

Hospital Cardiologica Aguascalientes

Aguascalientes, , Mexico

Site Status

Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

Culiacán, , Mexico

Site Status

Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

Guadalajara, , Mexico

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status

Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Guadalajara, , Mexico

Site Status

Centro Medico Jojutla

Jojutla, , Mexico

Site Status

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Site Status

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

Monterrey, , Mexico

Site Status

Clinical Trials Mexico S.A. de C.V.

Pahucha, , Mexico

Site Status

Huisartsenpraktijk Zijtregtop

Rotterdam, , Netherlands

Site Status

Huisartsenpraktijk Mangal

The Hague, , Netherlands

Site Status

Huisartsenpraktijk Top

Zwijndrecht, , Netherlands

Site Status

Southern Clinical Trials Ltd

Auckland, , New Zealand

Site Status

Culloden Research Ltd

Papamoa, , New Zealand

Site Status

Lakeland Family Medical Services Ltd

Rotorua, , New Zealand

Site Status

Wellington Hospital

Wellington, , New Zealand

Site Status

Complejo Hospitalario San Pablo

Lima, , Peru

Site Status

Clínica Sanna San Borja

Lima, , Peru

Site Status

Clínica Internacional

Lima, , Peru

Site Status

Hospital Maria Auxiliadora

Lima, , Peru

Site Status

Clinica Peruano Americana S.A

Trujillo, , Peru

Site Status

Malopolskie Centrum Alergologii

Krakow, , Poland

Site Status

ETG Lodz

Lodz, , Poland

Site Status

Powiatowe Centrum Medyczne w Wolowie Sp z o o

Specjalistyczna W Brzegu Dolnym, , Poland

Site Status

Gabinet Lekarski Pediatryczno-Alergologiczny

Sucha Beskidzka, , Poland

Site Status

NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Site Status

Centrum Medyczne w Lancucie Sp.z o.o.

Łańcut, , Poland

Site Status

Institute Of Epidimiology And Microbiology

Kazan', , Russia

Site Status

Limited Liability company 'MSMC' Euromed

Omsk, , Russia

Site Status

LLC Outpatient department of Private Security Guards and Detectives

Saint Petersburg, , Russia

Site Status

LLC Institute of Medical Examinations

Saint Petersburg, , Russia

Site Status

LLC Kurator

Saint Petersburg, , Russia

Site Status

FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF

Saint Petersburg, , Russia

Site Status

LLC 'ArsVite'

Stavropol, , Russia

Site Status

Siberian State Medical University

Tomsk, , Russia

Site Status

Clinical Hospital #3

Yaroslavl, , Russia

Site Status

SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF

Yaroslavl, , Russia

Site Status

Alersa, S.R.O.

Košice, , Slovakia

Site Status

Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

Michalovce, , Slovakia

Site Status

Plucna ambulancia Hrebenar, s.r.o.

Spišská Nová Ves, , Slovakia

Site Status

Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

Svidník, , Slovakia

Site Status

Cardiology Clinical Research

Alberton, , South Africa

Site Status

Josha Research

Bloemfontein, , South Africa

Site Status

Dr Dindar & Partner

Breyten, , South Africa

Site Status

Endocare Research

Cape Town, , South Africa

Site Status

Uhuru Clinical Trial Centre

Cape Town, , South Africa

Site Status

Dr EL Janari Private Practice

Cape Town, , South Africa

Site Status

Precise Clinical Solutions

Chatsworth, , South Africa

Site Status

Abdullah, IA

Durban, , South Africa

Site Status

Sebastian, Peter

Durban, , South Africa

Site Status

Pillai, P

Durban, , South Africa

Site Status

Govind, U

Durban, , South Africa

Site Status

Jeevren Reddy, MD

Durban, , South Africa

Site Status

Global Clinical Research SA

Durban North, , South Africa

Site Status

CRISMO Bertha Gxowa Research Centre

Johannesburg, , South Africa

Site Status

Peermed Clinical Trial Centre

Kempton Park, , South Africa

Site Status

DJW Research

Krugersdorp, , South Africa

Site Status

Aliwal Shoal Medical Centre

KwaZulu-Natal, , South Africa

Site Status

Dr A Jacovides Clinical Trials Inc.

Midrand, , South Africa

Site Status

Dr AA Mahomed Medical Centre

Moloto South, , South Africa

Site Status

Newtown Clinical Research

Newtown, , South Africa

Site Status

Pillay, SR

Ottawa, , South Africa

Site Status

Smartmed Research Centre

Port Elizabeth, , South Africa

Site Status

Emmed Research

Pretoria, , South Africa

Site Status

Botho ke Bontle Health Services

Pretoria, , South Africa

Site Status

Into Research

Pretoria, , South Africa

Site Status

Jongaie Research

Pretoria, , South Africa

Site Status

Queenswood Clinical Trial Centre

Pretoria, , South Africa

Site Status

Engelbrecht, I

Pretoria, , South Africa

Site Status

Johese Clinical Research

Pretoria, , South Africa

Site Status

Wits Clinical Research

Soweto, , South Africa

Site Status

Limpopo Clinical Research Initiative

Thabazimbi, , South Africa

Site Status

Clinteam Vaal Clinical Trial Centre

Van Der Bijl, , South Africa

Site Status

Welkom Clinical Trial Centre

Welkom, , South Africa

Site Status

Moriana Clinical Research

Winnie Mandela, , South Africa

Site Status

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, , South Korea

Site Status

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, , South Korea

Site Status

Dong-A University Hospital

Pusan, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

The Catholic university of Korea ST Vincent Hospital

Suwon, , South Korea

Site Status

Hosp. Gral. Univ. de Elche

Elche, , Spain

Site Status

Hosp. Univ. San Cecilio

Granada, , Spain

Site Status

Hosp. Univ. Virgen de Las Nieves

Granada, , Spain

Site Status

Hosp. Univ. de La Princesa

Madrid, , Spain

Site Status

Hosp. Clinico San Carlos

Madrid, , Spain

Site Status

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Site Status

Hosp. Univ. La Paz

Madrid, , Spain

Site Status

Hosp. Univ. Hm Monteprincipe

Madrid, , Spain

Site Status

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Site Status

Hosp. Alvaro Cunqueiro

Vigo, , Spain

Site Status

Department for Heart Failure and Valvular Disease

Malmo, , Sweden

Site Status

City Diabetes

Stockholm, , Sweden

Site Status

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status

Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

Taipei Medical University Shuang-Ho Hospital

New Taipei City, , Taiwan

Site Status

Kuang Tien General Hospital, Shalu

Taichung, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Medical University

Taipei, , Taiwan

Site Status

Taipei Medical University-Wan Fang Hospital

Taipei, , Taiwan

Site Status

The Hospital for Tropical Diseases

Bangkok, , Thailand

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Srinagarind Hospital

Muang, , Thailand

Site Status

Bamrasnaradura Infectious Disease Institute

Nonthaburi, , Thailand

Site Status

Bumrungrad Hospital

Wattana, , Thailand

Site Status

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Adnan Menderes University

Aydin, , Turkey (Türkiye)

Site Status

Uludag University Medical Faculty

Bursa, , Turkey (Türkiye)

Site Status

Diyarbakir University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Site Status

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status

Hacettepe University Medical Faculty

Samanpazarı, , Turkey (Türkiye)

Site Status

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

Site Status

Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE

Kharkiv, , Ukraine

Site Status

Kyiv Oleksandrivska Clinical Hospital

Kyiv, , Ukraine

Site Status

Odesa City Municipal Institution Polyclinic #20

Odesa, , Ukraine

Site Status

Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

Poltava, , Ukraine

Site Status

CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

Vinnytsia, , Ukraine

Site Status

Swan Lane Medical Centre

Bolton, , United Kingdom

Site Status

Bodey Medical Centre

Manchester, , United Kingdom

Site Status

Barlow Medical Centre

Manchester, , United Kingdom

Site Status

West Timperley Medical Centre

Manchester, , United Kingdom

Site Status

Northenden Group Practice

Northenden, , United Kingdom

Site Status

Bach Mai Hospital

Hanoi, , Vietnam

Site Status

National Hospital for Tropical Diseases

Hanoi, , Vietnam

Site Status

Nguyen Tri Phuong Hospital

Ho Chi Minh City, , Vietnam

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile China Czechia Estonia France Germany Hungary India Israel Italy Latvia Lithuania Malaysia Mexico Netherlands New Zealand Peru Poland Russia Slovakia South Africa South Korea Spain Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom Vietnam

References

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Leopold L, Vingerhoets J, Deleu S, Nalpas C, Weber K, van Dromme I, Lowson D, Michiels B, van Duijnhoven W. Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection. J Infect Dis. 2025 Feb 4;231(1):e132-e143. doi: 10.1093/infdis/jiae408.

Reference Type DERIVED
PMID: 39172627 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-002217-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

63623872FLZ3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108400

Identifier Type: -

Identifier Source: org_study_id

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