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

Influenza A Clinical Trial

Official title:

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03381196
• Other study ID #: CR108400
• Secondary ID: 2017-002217-5963
• Status: Terminated
• Phase: Phase 3
• Start date: January 21, 2018
• Est. completion date: August 24, 2020

Study information

• Verified date: April 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 (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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 553
• Est. completion date: August 24, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Influenza A
• Influenza, Human

Intervention

Drug:
• 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).
• 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).

Other:
• 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).

Locations

Country	Name	City	State
Argentina	Hospital Interzonal General de Agudos Dr. Jose Penna	Bahia Blanca
Argentina	CEMIC Saavedra	Ciudad de Buenos Aires
Argentina	Hospital Cordoba	Cordoba
Argentina	Hospital Nuestra Señora de la Misericordia	Cordoba
Argentina	Hospital Privado Centro Medico de Cordoba	Cordoba
Argentina	Sanatorio Allende	Cordoba
Argentina	Hospital Rawson	Córdoba
Argentina	Hospital San Roque	Córdoba
Argentina	Sanatorio Juan XXIII	General Roca
Argentina	Sanatorio del Oeste Ituzaingo	Ituzaingo
Argentina	Instituto Medico Platense	La Plata
Argentina	Hospital Italiano de La Plata	La Plata Lpl Lpl
Argentina	Sanatorio Britanico S.A.	Rosario
Argentina	Instituto Del Buen Aire	Santa Fe
Australia	Northside Health	Coffs Harbour
Australia	Mater Hospital Brisbane	South Brisbane
Austria	AKH - Medizinische Universität Wien	Wien
Austria	SMZ Süd - Kaiser Franz Josef Spital Wien	Wien
Belgium	Hopital Erasme	Brussel
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	Institut Jules Bordet	Bruxelles
Belgium	De Meulemeester, Marc	Gozée
Belgium	Jaak Mortelmans	Ham
Belgium	Quartier du Furgy 4	Herbeumont
Belgium	Research Link	Linkebeek
Belgium	BVBA Dr. Luc Capiau	Massemen
Belgium	Testumed	Tessenderlo
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Infection Control Ltda	Brasil
Brazil	Hrpc Ulbratech - Ulbra	Canoas
Brazil	Centro de Estudos Clínicos do Interior Paulista - CECIP	Jaú
Brazil	CMiP - Centro Mineiro de Pesquisa	Juiz de Fora
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre
Brazil	Hospital São Lucas da PUCRS	Porto Alegre
Brazil	CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.	Rio de Janeiro
Brazil	Pesquisare Saude	Santo André
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo do Campo
Brazil	Fundacao Jose Luiz Egydio Setubal	São Paulo
Brazil	Irmandade Da Santa Casa de Misericordia de Sao Paulo	São Paulo
Bulgaria	SHATPPD - Ruse Ltd.	Ruse
Bulgaria	Acibadem City Clinic Tokuda Hospital	Sofia
Bulgaria	DCC II- Sofia EOOD	Sofia
Bulgaria	Fifth MHAT - Sofia	Sofia
Bulgaria	Medical Center 'N. I. Pirogov', EOOD	Sofia
Bulgaria	Medical Center Excelsior OOD	Sofia
Bulgaria	MHAT 'Lyulin' EAD	Sofia
Bulgaria	Military Medical Academy - Sofia	Sofia
Bulgaria	MHAT Dr Stefan Cherkezov	Veliko Tarnovo
Bulgaria	MC 'Sv. Ivan Rilski', OOD	Vidin
Canada	Aggarwal and associates Ltd	Brampton	Ontario
Canada	Commonwealth Medical Clinic	Mount Pearl
Canada	SKDS Research Inc.	NewMarket	Ontario
Canada	Recherche Clinique Sigma Inc.	Quebec
Canada	The Bailey Clinic	Red Deer	Alberta
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Dr. Anil K Gupta Medicine Professional Corporation	Toronto	Ontario
Chile	Hospital El Pino	San Bernardo
Chile	Centro de Investigacion del Maule	Talca
Chile	Hospital de Niños y Cunas	Viña
China	Chinese PLA General Hospital	Beijing
China	Fuzhou General Hospital of Nanjing Military Command	Fuzhou
China	The First Affiliated Hospital of NanChang University	NanChang
China	Wuxi People's Hospital	Wuxi
China	Henan province people's hospital	Zhengzhou
Czechia	ADMED s.r.o.	Ceske Budejovice
Czechia	Sanare, s.r.o.	Ceské Budejovice
Czechia	Nemocnice Kyjov, p.o.	Kyjov
Czechia	Praktik Pb s.r.o	Pribram
Czechia	SARKAMED s.r.o.	Slany
Czechia	Prakticky lekar	Sokolov
Estonia	Private GP Ilme Last	Paide
Estonia	Vee Family Doctor's Center OY	Paide
Estonia	Merelahe Family Doctors Center	Tallinn
Estonia	OU Innomedica	Tallinn
Estonia	Pirita Family Doctors Centre	Tallinn
Estonia	Family Doctors Pullerits & Gavronski	Tartu
France	Centre Hospitalier d'Agen	Agen cedex 9
France	Centre Hospitalier Intercommunal de Créteil	Creteil cedex
France	Centre Hospitalier Départemental	La Roche S/ Yon Cedex 9
France	CHU de Grenoble - Hôpital Albert Michallon	La Tronche
France	CHU Nantes - Hotel Dieu	Nantes Cedex 1
France	CHU de Nice, Hopital de l'Archet	Nice Cedex 3
France	Hôpital Bichat - Claude Bernard	Paris
France	Hopital Cochin	Paris 75
Germany	MECS GmbH Cottbus	Cottbus
Germany	Jung, Thomas	Deggingen
Germany	Universitaetsklinik Erlangen	Erlangen
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Giessen
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Gemeinschaftspraxis Dr. Klein/ Minnich	Kuenzing
Germany	Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut	Leipzig
Hungary	DRC Gyogyszervizsgalo Kozpont Kft	Balatonfured
Hungary	Clinexpert Kft.	Budapest
Hungary	Egeszsegkert Medicina Bt.	Budapest
Hungary	Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelo Budai Családközpontú	Budapest
Hungary	Obudai Egeszsegugyi Centrum Kft.	Budapest
Hungary	Pestszentimrei Gyermekrendelo	Budapest
Hungary	Bugat Pal Korhaz	Gyongyos
Hungary	Futurenest Klinikai Kutato Kft.	Miskolc
Hungary	Mohacsi Korhaz	Mohacs
Hungary	Borbanya Praxis Eu. Kft.	Nyiregyhaza
Hungary	Medifarma-98 Kft.	Nyiregyhaza
Hungary	DRC Szentendre	Szentendre
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
Hungary	DRC Zamardi	Zamardi
Hungary	DRC Zirc	Zirc
India	Rajiv Gandhi Institute of Medical Sciences	Balaga
India	M S Ramaiah Memorial Hospital	Bangalore
India	S. R. Kalla Memorial General Hospital	Jaipur
India	Midland Healthcare & Research Center	Lucknow
India	Kasturba Medical College Hospital	Manipal
India	Suretech Hospital and Research Centre Limited	Nagpur
India	Siddhi Hospital	Nashik
India	BLK Super Specialty Hospital	New Delhi
India	Sir Ganga Ram Hospital	New Delhi
India	Lifepoint Multispecialty Hospital	Pune
India	Sahyadri Speciality Hospital	Pune
India	Shree Giriraj Multispeciality Hospital	Rajkot
India	BAPS Pramukhswami Hospital	Surat
India	Unique Hospital	Surat
Israel	Barzilai Medical Center	Ashkelon
Israel	Bnai Zion Medical Center	Haifa
Israel	Galilee Medical Center	Nahariya
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Ziv Medical Center	Safed
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	AOU Policlinico di Modena	Modena
Italy	Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo	Monza
Italy	Azienda Ospedaliera Universitaria Integrata Verona	Verona
Korea, Republic of	Korea University Ansan Hospital	Ansan-si
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Gangwon-do
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	The Catholic university of Korea, ST Vincent Hospital	Suwon-si
Latvia	Liga Kozlovska family doctor practice	Balvi
Latvia	OLVI Medical Centre	Daugavpils
Latvia	Baiba Bake GP practice	Jelgava
Latvia	Ruta Eglite's Private Practice	Kuldiga
Latvia	Inese Cebere GP practice	Liepaja
Latvia	S. Boreiko Doctor's Practice	Ogre
Latvia	Children's Clinical University Hospital	Riga
Latvia	Clinic of GP A.Lasmanis 'ALMA'	Riga
Latvia	Health Centre 4	Riga
Latvia	Inese Petrova General Practitioner Practice	Tukums
Latvia	Medical Practice BINI	Ventspils
Lithuania	Auki Sveikas	Kaunas
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Saules Seimos Medicinos Centras, JSC	Kaunas
Lithuania	Silainiai Family Health Center, JSC	Kaunas
Lithuania	Siauliai Republican Hospital, Public Institution	Siauliai
Lithuania	Central Outpatient Clinic	Vilnius
Lithuania	Inlita, JSC	Vilnius
Lithuania	Inlita, JSC, Lazdynai KTC clinical trial site	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos, Public Institution	Vilnius
Malaysia	Klinik Kesihatan Cheras Baru	Cheras Baru
Malaysia	Klinik Kesihatan Kuang	Kuang
Malaysia	Hospital Miri	Miri
Malaysia	Hospital Taiping	Taiping
Mexico	Hospital Cardiologica Aguascalientes	Aguascalientes
Mexico	Hospital Infantil de Mexico Federico Gomez	Ciudad De Mexico
Mexico	Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.	Culiacan
Mexico	Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA	Guadalajara
Mexico	Hospital Civil de Guadalajara Dr. Juan I. Menchaca	Guadalajara
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	Centro Medico Jojutla	Jojutla De Juárez
Mexico	Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'	Monterrey
Mexico	Clinical Trials Mexico S.A. de C.V.	Pahucha
Netherlands	Huisartsenpraktijk Mangal	Den Haag
Netherlands	Huisartsenpraktijk Zijtregtop	Rotterdam
Netherlands	Huisartsenpraktijk Top	Zwijndrecht
New Zealand	Southern Clinical Trials Ltd	Auckland
New Zealand	Culloden Research Ltd	Papamoa
New Zealand	Lakeland Family Medical Services Ltd	Rotorua
New Zealand	Wellington Hospital	Wellington
Peru	Clínica Internacional	Lima
Peru	Clínica Sanna San Borja	Lima
Peru	Complejo Hospitalario San Pablo	Lima
Peru	Hospital Maria Auxiliadora	Lima
Peru	Clinica Peruano Americana S.A	Trujillo
Poland	Malopolskie Centrum Alergologii	Krakow
Poland	Centrum Medyczne w Lancucie Sp.z o.o.	Lancut
Poland	ETG Lodz	Lodz
Poland	Powiatowe Centrum Medyczne w Wolowie Sp. z o.o.	Specjalistyczna W Brzegu Dolnym
Poland	Gabinet Lekarski Pediatryczno-Alergologiczny	Sucha Beskidzka
Poland	NZOZ Centrum Badan Klinicznych,Piotr Napora,Lekarze Spólka Partnerska	Wroclaw
Russian Federation	Institute Of Epidimiology And Microbiology	Kazan
Russian Federation	Limited Liability company 'MSMC' Euromed	Omsk
Russian Federation	FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF	Saint-Petersburg
Russian Federation	LLC Institute of Medical Examinations	Saint-Petersburg
Russian Federation	LLC Outpatient department of Private Security Guards and Detectives	Saint-Petersburg
Russian Federation	LLC Kurator	St. Petersburg
Russian Federation	LLC 'ArsVite'	Stavropol
Russian Federation	Siberian State Medical University	Tomsk
Russian Federation	Clinical Hospital #3	Yaroslavl
Russian Federation	SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF	Yaroslavl
Slovakia	Alersa, S.R.O.	Kosice
Slovakia	Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.	Michalovce
Slovakia	Plucna ambulancia Hrebenar, s.r.o.	Spisska Nova Ves
Slovakia	Nemocnica arm. generala L. Svobodu Svidnik, a.s.,	Svidnik
South Africa	Cardiology Clinical Research	Alberton
South Africa	Josha Research	Bloemfontein
South Africa	Moriana Clinical Research	Brandfort
South Africa	Dr Dindar & Partner	Breyten
South Africa	Dr EL Janari Private Practice	Cape Town
South Africa	Endocare Research	Cape Town
South Africa	Uhuru Clinical Trial Centre	Cape Town
South Africa	Precise Clinical Solutions	Chatsworth
South Africa	Abdullah, IA	Durban
South Africa	Govind, U	Durban
South Africa	Jeevren Reddy, MD	Durban
South Africa	Pillai, P	Durban
South Africa	Sebastian, Peter	Durban
South Africa	Global Clinical Research SA	Durban North
South Africa	CRISMO Bertha Gxowa Research Centre	Johannesburg
South Africa	Peermed Clinical Trial Centre	Kempton Park
South Africa	DJW Research	Krugersdorp
South Africa	Aliwal Shoal Medical Centre	KwaZulu-Natal
South Africa	Dr A Jacovides Clinical Trials Inc.	Midrand
South Africa	Dr AA Mahomed Medical Centre	Moloto
South Africa	Newtown Clinical Research	Newtown
South Africa	Pillay, SR	Ottawa
South Africa	Smartmed Research Centre	Port Elizabeth
South Africa	Botho ke Bontle Health Services	Pretoria
South Africa	Emmed Research	Pretoria
South Africa	Engelbrecht, I	Pretoria
South Africa	Into Research	Pretoria
South Africa	Johese Clinical Research	Pretoria
South Africa	Jongaie Research	Pretoria
South Africa	Queenswood Clinical Trial Centre	Pretoria
South Africa	Wits Clinical Research	Soweto
South Africa	Limpopo Clinical Research Initiative	Thabazimbi
South Africa	Clinteam Vaal Clinical Trial Centre	Van Der Bijl
South Africa	Welkom Clinical Trial Centre	Welkom
Spain	Hosp. Gral. Univ. de Elche	Elche
Spain	Hosp. Univ. San Cecilio	Granada
Spain	Hosp. Univ. Virgen de Las Nieves	Granada
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. de La Princesa	Madrid
Spain	Hosp. Univ. Hm Monteprincipe	Madrid
Spain	Hosp. Univ. La Paz	Madrid
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Alvaro Cunqueiro	Vigo
Sweden	Department for Heart Failure and Valvular Disease	Malmö
Sweden	City Diabetes	Stockholm
Sweden	Norrlands Universitetssjukhus	Umeå
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	Taipei Medical University Shuang-Ho Hospital	New Taipei City
Taiwan	Kuang Tien General Hospital, Shalu	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Wan Fang Hospital	Taipei
Taiwan	Taipei Medical University	Taipei City
Thailand	Siriraj Hospital	Bangkok
Thailand	The Hospital for Tropical Diseases	Bangkok
Thailand	Srinagarind Hospital	Muang
Thailand	Bamrasnaradura Infectious Disease Institute	Nonthaburi
Thailand	Bumrungrad Hospital	Wattana
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Adnan Menderes University	Aydin
Turkey	Uludag University Medical Faculty	Bursa
Turkey	Diyarbakir University Medical Faculty	Diyarbakir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Hacettepe University Medical Faculty	Samanpazari, Altindag
Turkey	Karadeniz Teknik University Medical Faculty	Trabzon
Ukraine	Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE	Kharkiv
Ukraine	Kyiv Oleksandrivska Clinical Hospital	Kyiv
Ukraine	Odesa City Municipal Institution Polyclinic #20	Odesa
Ukraine	Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy	Poltava
Ukraine	CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM	Vinnytsia
United Kingdom	Swan Lane Medical Centre	Bolton
United Kingdom	Barlow Medical Centre	Manchester
United Kingdom	Bodey Medical Centre	Manchester
United Kingdom	West Timperley Medical Centre	Manchester
United Kingdom	Northenden Group Practice	Northenden
United States	HIRG, LLC dba Health Innovation Research Group	Arlington	Texas
United States	Millennium Clinical Trials, LLC	Arlington	Virginia
United States	ACRC Trials	Austin	Texas
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	University Of Maryland Medical Center	Baltimore	Maryland
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Cahaba Research Inc	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Val Hansen	Bountiful	Utah
United States	Craig A. Spiegel, MD	Bridgeton	Missouri
United States	PMG Research of Bristol	Bristol	Tennessee
United States	Investigators Research Group, LLC	Brownsburg	Indiana
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	SC Clinical Research Inc.	California City	California
United States	Family Medicine Associates of Texas	Carrollton	Texas
United States	PMG Research	Cary	North Carolina
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Onsite Clinical Solutions	Clemmons	North Carolina
United States	Ericksen Research and Development	Clinton	Utah
United States	Lynn Institute	Colorado Springs	Colorado
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	WR-Global Medical Research, LLC	DeSoto	Texas
United States	Wayne State Univ School of Medicine	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Moonshine Research Center, Inc	Doral	Florida
United States	J. Lewis research Inc./ Foothill Family Clinic South	Draper	Utah
United States	Centennial Medical Group	Elkridge	Maryland
United States	Medisphere Medical Research Center, Llc	Evansville	Indiana
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Research Center of Fresno Inc	Fresno	California
United States	Spectrum Medical Research	Gaffney	South Carolina
United States	University Of Texas Medical Branch At Galveston	Galveston	Texas
United States	clinical research of Gastonia	Gastonia	North Carolina
United States	San Gabriel Clinical Research, LLC	Georgetown	Texas
United States	Allied Clinical Research	Gold River	California
United States	DeGarmo Institute of Medical Research	Greer	South Carolina
United States	Innovative Clinical Research, Inc.	Harbor City	California
United States	Best Quality Research Inc	Hialeah	Florida
United States	Floridian Clinical Research, LLC	Hialeah	Florida
United States	The community Research of South Florida	Hialeah	Florida
United States	Hickory Research Center.	Hickory	North Carolina
United States	Buckeye Health and Research, LLC	Hilliard	Ohio
United States	Encore Medical Research, LLC	Hollywood	Florida
United States	Homestead Associates in Research, Inc	Homestead	Florida
United States	BI Research Center	Houston	Texas
United States	Dairy Ashford Family Practice	Houston	Texas
United States	JM Research.PLLC	Houston	Texas
United States	Northwest Med Care,P.A.	Houston	Texas
United States	PCP for Life	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	West Houston Clinical Research Service	Houston	Texas
United States	Hutchinson Clinic	Hutchinson	Kansas
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	Care Partners Clinical Research	Jacksonville	Florida
United States	PMG Research of Knoxville	Jefferson City	Tennessee
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	Barrett Clinic P.C.	La Vista	Nebraska
United States	Premier Medical Group	Lady Lake	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Om Research LLC	Lancaster	California
United States	Detweiler Family Medicine and Associates	Lansdale	Pennsylvania
United States	Next Phase Research Alliance	Las Vegas	Nevada
United States	The Research Group of Lexington, LLC	Lexington	Kentucky
United States	Ark Clinical Research	Long Beach	California
United States	Miller Children's Hospital	Long Beach	California
United States	Adam D. Karns, MD	Los Angeles	California
United States	California Allergy & Asthma Medical Group Inc.	Los Angeles	California
United States	Downtown LA Research Center, Inc	Los Angeles	California
United States	SMS Clinical Research LLC	Mesquite	Texas
United States	Clinical Trials Management, LLC	Metairie	Louisiana
United States	Medpharmics, LLC	Metairie	Louisiana
United States	A Plus Research	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	Nuren Medical & Research Center	Miami	Florida
United States	Sima Research Clinic	Miami	Florida
United States	South Florida Research Center Inc.	Miami	Florida
United States	Universal Clinical Research Associates	Miami	Florida
United States	Vista Health Research, LLC	Miami	Florida
United States	Crystal Biomedical Research	Miami Lakes	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Burke Primary Care	Morganton	North Carolina
United States	PMG Research of Charleston, LLC	Mount Pleasant	South Carolina
United States	Saltzer Medical Group	Nampa	Idaho
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Complete Family Care	Northglenn	Colorado
United States	Lucita M. Cruz Md Inc	Norwalk	California
United States	Advanced Research Institute	Ogden	Utah
United States	Nebraska Medical Center	Omaha	Nebraska
United States	Clinical NeuroScience Solutions, Inc	Orlando	Florida
United States	Combined Research Orlando	Orlando	Florida
United States	Omega Research Consultants	Orlando	Florida
United States	Asclepes Research	Panorama City	California
United States	Center for Clinical Trials LLC	Paramount	California
United States	Pines Care Research Center Inc	Pembroke Pines	Florida
United States	South Broward Research, LLC	Pembroke Pines	Florida
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians Research	Pittsburgh	Pennsylvania
United States	Village Health Partners	Plano	Texas
United States	Health Concepts	Rapid City	South Dakota
United States	Granger Medical Clinic-Riverton	Riverton	Utah
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Benchmark Research	Sacramento	California
United States	J. Lewis research Inc./ Foothill Family Care	Salt Lake City	Utah
United States	J. Lewis research Inc./ Foothill Family Clinic South	Salt Lake City	Utah
United States	J. Lewis Research Inc/ FirstMed East	Salt Lake City	Utah
United States	DM Clinical Research	San Antonio	Texas
United States	Tekton Research Inc.	San Antonio	Texas
United States	Medical Associates Research Group, Inc.	San Diego	California
United States	San Diego Sports Medicine & Family Health Center	San Diego	California
United States	West Coast Clinical Research, LLC	San Ramon	California
United States	Destin Pulmonary Critical Care, PLLS.	Santa Rosa Beach	Florida
United States	Scottsboro Quick Care Clinic	Scottsboro	Alabama
United States	North Star Clinical Research, LLC	Shreveport	Louisiana
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	J. Lewis Research Inc./Jordan River Family Medicine	South Jordan	Utah
United States	Fusion Clinical Research of Spartanburg	Spartanburg	South Carolina
United States	Stanford University	Stanford	California
United States	Tri County Research, Inc.	Sterling Heights	Michigan
United States	Vita Health and Medical center	Tamarac	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	Arcturus Healthcare, PLC	Troy	Michigan
United States	William Beaumont Hospital	Troy	Michigan
United States	Preferred Primary Care Physicians Research	Uniontown	Pennsylvania
United States	AAPRI Clinical Research Institute	Warwick	Rhode Island
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	ClinPoint Trials	Waxahachie	Texas
United States	Asclepes Research	Weeki Wachee	Florida
United States	Axcess Medical Research, LLC	Wellington	Florida
United States	Invocare Clinical Research Center	West Columbia	South Carolina
United States	Paradigm Clinical Research Centers, Inc.	Wheat Ridge	Colorado
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	Clinical Trials of America	Winston-Salem	North Carolina
United States	Southeastern Research Center LLC	Winston-Salem	North Carolina
United States	Cozy Research, Llc	Zephyrhills	Florida
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	National Hospital for Tropical Diseases	Hanoi
Vietnam	Nguyen Tri Phuong Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)	The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.	Up to Day 28
Secondary	Number of Participants Hospitalized After Treatment Initiation	The number of participants hospitalized after treatment initiation were reported.	Up to Day 28
Secondary	Viral Load Over Time	Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.	Baseline, Day 3, 6, 10, 14
Secondary	Number of Participants With Emergence of Viral Resistance to Pimodivir	Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).	Up to Day 28
Secondary	Plasma Concentration of Pimodivir	Plasma concentration of Pimodivir was reported.	Day 3, 6, 7
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to Day 28
Secondary	Number of Participants With Clinically Significant Changes in Laboratory Tests	Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.	Up to Day 28
Secondary	Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.	Up to Day 28
Secondary	Number of Participants With Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.	Up to Day 28