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

Influenza A Clinical Trial

Official title:

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03376321
• Other study ID #: CR108399
• Secondary ID: 2017-002156-8463
• Status: Terminated
• Phase: Phase 3
• Start date: January 3, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: March 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, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 334
• Est. completion date: April 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 85 Years

Eligibility

Inclusion Criteria:

• Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay

• Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU)

• Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms

• Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening

• Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4

Exclusion Criteria:

• Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one 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, any history of a lung transplant)

• Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients

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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).
• 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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).

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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.

Locations

Country	Name	City	State
Argentina	Hospital Interzonal General de Agudos Dr. Jose Penna	Bahia Blanca
Argentina	CEMIC (Centro de Educación Médica e Investigaciones Clínicas)	C.a.b.a.
Argentina	Hospital Cordoba	Cordoba
Argentina	Hospital Nuestra Señora de la Misericordia	Cordoba
Argentina	Hospital Privado Centro Medico de Cordoba	Cordoba
Argentina	Hospital Rawson	Córdoba
Argentina	Hospital San Roque	Córdoba
Argentina	Sanatorio Juan XXIII	General Roca
Argentina	Instituto Medico Platense	La Plata
Argentina	Hospital Italiano de La Plata	La Plata Lpl Lpl
Argentina	Hospital Universitario Austral	Pilar
Argentina	Sanatorio Britanico S.A.	Rosario
Australia	Flinders Medical Centre	Bedford Park
Australia	Box Hill Hospital	Box Hill
Australia	Royal Melbourne Hospital	Melbourne
Australia	The Alfred Hospital	Melbourne
Australia	Mater Hospital Brisbane	South Brisbane
Australia	Townsville Hospital	Townsville
Austria	AKH - Medizinische Universität Wien	Wien
Austria	SMZ Süd - Kaiser Franz Josef Spital Wien	Wien
Austria	Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital	Wien
Belgium	Institut Jules Bordet	Brussel
Belgium	CHU Saint-Pierre	Bruxelles
Belgium	ULB Hôpital Erasme	Bruxelles
Brazil	Cardresearch - Cardiologia Assistencial	Belo Horizonte
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Infection Control Ltda	Brasil
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	Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio	Porto Alegre
Brazil	Hospital de Medicina de São José do Rio Preto	São José do Rio Preto
Brazil	Hospital da Luz	Sao Paulo
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	Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD	Sofia
Bulgaria	Military Medical Academy - Sofia	Sofia
Bulgaria	Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD	Sofia
Bulgaria	SHATPPD - Sofia District EOOD	Sofia
Bulgaria	MHAT Dr Stefan Cherkezov	Veliko Tarnovo
Canada	Health Sciences North Horizon Sante-Nord	Sudbury	Ontario
Canada	University of British Columbia	Vancouver
Chile	Hospital Dr Sotero del Rio	Puente Alto
Chile	Hospital El Pino	San Bernardo
China	The Third Xiangya Hospital, Central South University	Changsha
China	Nanfang Hospital	Guangzhou
China	Wuxi People's Hospital	Wuxi
China	Henan province people's hospital	Zhengzhou
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Nemocnice Kyjov, p.o.	Kyjov
Czechia	Nemocnice Na Bulovce	Praha 8
France	Centre Hospitalier d'Agen	Agen cedex 9
France	CHU Amiens - Hopital Sud	Amiens Cedex
France	Hopital Louis Mourier	Colombes
France	Centre Hospitalier Intercommunal de Créteil	Creteil cedex
France	CHU Dijon	Dijon
France	Centre Hospitalier Départemental	La Roche S/ Yon Cedex 9
France	CHU de Grenoble - Hôpital Albert Michallon	La Tronche
France	CHU de Limoges, Hopital Dupuytren	Limoges
France	Hopital Edouard Herriot - CHU Lyon	Lyon
France	Hôpital Nord - Marseille	Marseille cedex 20
France	CHU Nantes - Hotel Dieu	NANTES Cedex 01
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
France	Hopital Saint-Louis	Paris cedex 10
France	CHU Poitiers - Hôpital la Milétrie	Poitiers
France	CHU Saint-Etienne - Hôpital Nord	Saint-Etienne Cedex 2
Germany	Klinikum Donaustauf	Donaustauf
Germany	Universitaetsklinik Erlangen	Erlangen
Germany	Universitaetsklinikum Giessen und Marburg GmbH	Hessen
Germany	Universitaetsklinikum Koeln	Koeln
Germany	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck	Luebeck
Germany	Klinikum Weiden	Weiden
Hungary	Veszprem Megyei Tudogyogyintezete	Farkasgyepü
Hungary	Tudogyogyintezet Torokbalint	Torokbalint
India	Zydus Hospital-Ahmedabad	Ahmedabad
India	Rajiv Gandhi Institute of Medical Sciences	Balaga
India	M S Ramaiah Memorial Hospital	Bangalore
India	Apollo Hospitals International Limited	Gandhinagar
India	Aware Global Hospital	Hyderabad
India	Eternal Heart Care Centre	Jaipur
India	S. R. Kalla Memorial General Hospital	Jaipur
India	Ajanta Research Cemtre	Lucknow
India	Midland Healthcare & Research Center	Lucknow
India	Vinaya Hospital and Research Center	Mangalore
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	Fortis Flight Lieutenant Rajan Dhall 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
Israel	Haemek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Medical Center	Beersheba
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Hadassah University Hospita - Ein Kerem	Jerusalem
Israel	Sapir Medical Center, Meir Hospital	Kfar-Saba
Israel	Galilee Medical Center	Nahariya
Israel	Rabin Medical Center, Beilinson Campus	Petach Tikva
Israel	Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rechovot
Israel	Ziv Medical Center	Safed
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena	Milano
Italy	Ospedale San Giuseppe - Fatebenefratelli	Milano
Italy	Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro	Milano
Italy	AOU Policlinico di Modena	Modena
Italy	Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo	Monza
Italy	Azienda Ospedaliera Universitaria Maggiore della Carità	Novara
Italy	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone	Palermo
Italy	Lazzaro Spallanzani IRCCS	Roma
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	Gachon University Gil Medical Center	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's Hospital	Suwon-si
Latvia	Regional Hospital of Liepaja	Liepaja
Latvia	Hospital of Rezekne	Rezekne
Latvia	Children's Clinical University Hospital	Riga
Latvia	Pauls Stradins Clinical University Hospital	Riga
Latvia	Riga East Clinical University Hospital	Riga
Latvia	Centre of Tuberculosis and Lung Diseases	Riga District
Latvia	Vidzemes Hospital	Valmiera
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	Siauliai Republican Hospital, Public Institution	Siauliai
Lithuania	Infectious Diseases Center of Vilnius University Hospital Santaros klinikos	Vilnius
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Queen Elizabeth	Kota Kinabalu
Malaysia	Hospital Sultanah Nur Zahirah	Kuala
Malaysia	Hospital Umum Sarawak	Kuching
Malaysia	Hospital Miri	Miri
Malaysia	Hospital Tuanku Jaafar	Seremban
Malaysia	Hospital Sibu	Sibu
Malaysia	Hospital Sungai Buloh	Sungai Buloh
Malaysia	Hospital Taiping	Taiping
Mexico	Hospital Infantil de Mexico Federico Gomez	Ciudad De Mexico
Mexico	JM Research, SC	Cuernavaca
Mexico	Hospital Civil de Guadalajara Dr. Juan I. Menchaca	Guadalajara
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara
Mexico	Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'	Mexico
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Jeroen Bosch Ziekenhuis	s-Hertogenbosch
Netherlands	UMC Utrecht	Utrecht
Netherlands	Gelre Ziekenhuizen Zutphen	Zutphen
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Waikato Hospital	Hamilton
New Zealand	Tauranga Hospital	Tauranga
New Zealand	Wellington Hospital	Wellington
Peru	Clinica Peruano Americana S.A	Trujillo
Poland	Szpital Miejski ZOZ	Debica
Poland	Centrum Medyczne w Lancucie Sp.z o.o.	Lancut
Poland	NZOZ Centrum Badan Klinicznych,Piotr Napora,Lekarze Spólka Partnerska	Wroclaw
Russian Federation	City Hospital #8	Chelyabinsk
Russian Federation	Clinical Infectious Diseases Hospital n. a. S.P. Botkin	Saint-Petersburg
Russian Federation	Clinical Infectious Diseases Hospital n. a. S.P. Botkin	St. Petersburg
Russian Federation	LLC Reafarm	Stavropol
Russian Federation	Clinical Hospital #3	Yaroslavl
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Slovakia	DFNsP Bratislava	Bratislava
Slovakia	Nemocnica Malacky, Nemocnicna A.S.	Malacky
Slovakia	Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.	Michalovce
Slovakia	Nemocnica arm. generala L. Svobodu Svidnik, a.s.,	Svidnik
South Africa	Clinical Research Centre University of Cape Town	Cape Town
South Africa	Johese Unitas	Centurion
South Africa	Abdullah, IA	Durban
South Africa	Sebastian, Peter	Durban
South Africa	DJW Research	Krugersdorp
South Africa	Emmed Research	Pretoria
South Africa	Into Research	Pretoria
South Africa	Limpopo Clinical Research Initiative	Thabazimbi
Spain	Hosp. Clinic I Provincial de Barcelona	Barcelona
Spain	Hosp. Univ. Donostia	Donostia-San Sebastian
Spain	Hosp. Gral. Univ. de Elche	Elche
Spain	Hosp. Univ. de Getafe	Getafe
Spain	Hosp. Univ. San Cecilio	Granada
Spain	Hosp. Univ. Virgen de Las Nieves	Granada
Spain	Hosp. Univ. de Bellvitge	L'Hospitalet de Llobregat
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. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. De Mataro	Mataro
Spain	Hosp. Clinico Univ. de Santiago	Santiago de Compostela
Spain	Hosp. Mutua Terrassa	Terrassa
Spain	Hosp. Alvaro Cunqueiro	Vigo
Sweden	Department for Heart Failure and Valvular Disease	Malmö
Sweden	Norrlands Universitetssjukhus	Umeå
Sweden	Akademiska Sjukhuset	Uppsala
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Wan Fang Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Thailand	Siriraj Hospital	Bangkok
Thailand	Bamrasnaradura Infectious Disease Institute	Muang
Thailand	Srinagarind Hospital	Muang
Thailand	Bumrungrad Hospital	Wattana
Turkey	Hacettepe University Medical Faculty	Ankara
Turkey	Adnan Menderes University	Aydin
Turkey	Dicle 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	Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.	Kharkiv
Ukraine	Kyiv Oleksandrivska Clinical Hospital	Kyiv
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
Ukraine	Communal Institution Central City Hospital	Zhytomyr
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	North Manchester General Hospital	Manchester
United Kingdom	Musgrove Park Hospital	Taunton
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Northside Hospital	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University Of Maryland Medical Center	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center PRIME	Bronx	New York
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Lowcountry Infectious Diseases	Charleston	South Carolina
United States	UC Health LLC	Cincinnati	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State Univ School of Medicine	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	UCSF Fresno	Fresno	California
United States	Nea Baptist Clinic	Jonesboro	Arkansas
United States	Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research	Kalamazoo	Michigan
United States	Miller Children's at Long Beach Medical Center	Long Beach	California
United States	Regents of the University of Minnesota	Minneapolis	Minnesota
United States	Saint Michael's Medical Center	Newark	New Jersey
United States	Rhode Island Hospital	Providence	Rhode Island
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University	Saint Louis	Missouri
United States	Destin Pulmonary Critical Care, PLLS.	Santa Rosa Beach	Florida
United States	Stanford University School of Medicine	Stanford	California
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	DM Clinical Research	Tomball	Texas
United States	William Beaumont Hospital	Troy	Michigan
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	National Hospital for Tropical Diseases	Hanoi
Vietnam	Thanh Nhan Hospital	Hanoi
Vietnam	Children's Hospital 1	Ho Chi Minh
Vietnam	Children's Hospital 2	Ho Chi Minh
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,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Russian Federation,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hospital Recovery Scale on Day 6	The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.	Day 6
Secondary	Time to Hospital Discharge	The time to hospital discharge was defined as the time from start of study drug to hospital discharge.	Up to Day 33
Secondary	Number of Participants With Adjudicated Influenza Complications	Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).	Up to Day 33
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, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
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 33
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 33
Secondary	Plasma Concentration of Pimodivir	Plasma concentration of Pimodivir was reported.	Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose
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 were collected at predefined time points for clinical laboratory testing.	Up to Day 33
Secondary	Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.	Up to Day 33
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) was reported.	Up to Day 33