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

NCT ID: NCT03376321

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2020-04-30

Brief 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.

Detailed 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.

Conditions

Influenza A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm 1 (pimodivir + Standard-of-Care [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 SOC treatment. Participants who meet all treatment extension criteria as defined in the protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment is determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of SOC cannot be changed (example, switching one influenza antiviral for another) during either treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in case of 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). 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).

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 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.

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 morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment determined by investigator based on local practice, 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 of first study drug intake. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either treatment period/extension phase, with the exception that an influenza antiviral may be discontinued in 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). 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).

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 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.

Interventions

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).

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). 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).

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 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Nea Baptist Clinic

Jonesboro, Arkansas, United States

UCSF Fresno

Fresno, California, United States

Miller Children's at Long Beach Medical Center

Long Beach, California, United States

Stanford University School of Medicine

Stanford, California, United States

Destin Pulmonary Critical Care, PLLS.

Santa Rosa Beach, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

University Of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Wayne State Univ School of Medicine

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

Kalamazoo, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

William Beaumont Hospital

Troy, Michigan, United States

Regents of the University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Saint Michaels Medical Center

Newark, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

Montefiore Medical Center PRIME

The Bronx, New York, United States

UC Health LLC

Cincinnati, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Lowcountry Infectious Diseases

Charleston, South Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, , Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

C.a.b.a., , Argentina

Hospital Nuestra Señora de la Misericordia

Córdoba, , Argentina

Hospital Rawson

Córdoba, , Argentina

Hospital San Roque

Córdoba, , Argentina

Hospital Cordoba

Córdoba, , Argentina

Hospital Privado Centro Medico de Cordoba

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, , Argentina

Flinders Medical Centre

Bedford Park, , Australia

Box Hill Hospital

Box Hill, , Australia

The Alfred Hospital

Melbourne, , Australia

Royal Melbourne Hospital

Melbourne, , Australia

Mater Hospital Brisbane

South Brisbane, , Australia

Townsville Hospital

Townsville, , Australia

AKH - Medizinische Universitat Wien

Vienna, , Austria

SMZ Süd - Kaiser Franz Josef Spital Wien

Vienna, , Austria

Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital

Vienna, , Austria

CHU Saint-Pierre

Brussels, , Belgium

Institut Jules Bordet

Brussels, , Belgium

ULB Hôpital Erasme

Brussels, , Belgium

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, , Brazil

Cardresearch - Cardiologia Assistencial

Belo Horizonte, , Brazil

Infection Control Ltda

Brasil, , Brazil

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

Passo Fundo, , Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, , Brazil

Irmandade Santa Casa de Misericordia de Sao Paulo

São Paulo, , Brazil

Fundacao Jose Luiz Egydio Setubal

São Paulo, , Brazil

Hosp. Da Luz Lisboa

São Paulo, , Brazil

SHATPPD - Ruse Ltd.

Rousse, , Bulgaria

SHATPPD - Sofia District EOOD

Sofia, , Bulgaria

Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

Sofia, , Bulgaria

Military Medical Academy - Sofia

Sofia, , Bulgaria

MHAT Dr Stefan Cherkezov

Veliko Tarnovo, , Bulgaria

University of British Columbia

Vancouver, British Columbia, Canada

Health Sciences North Horizon Sante-Nord

Greater Sudbury, Ontario, Canada

Hospital Dr Sotero del Rio

Puente Alto, , Chile

Hospital El Pino

San Bernardo, , Chile

The Third Xiangya Hospital, Central South University

Changsha, , China

Nanfang Hospital

Guangzhou, , China

Wuxi People s Hospital

Wuxi, , China

Henan Provincial Peoples Hospital

Zhengzhou, , China

Fakultni nemocnice Brno

Brno, , Czechia

Nemocnice Kyjov, p.o.

Kyjov, , Czechia

Nemocnice Na Bulovce

Prague, , Czechia

Centre Hospitalier d'Agen

Agen, , France

CHU Amiens - Hopital Sud

Amiens, , France

Hopital Louis Mourier

Colombes, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

CHU Dijon

Dijon, , France

Centre Hospitalier Départemental

La Roche S/ Yon Cedex 9, , France

CHU de Grenoble Hopital Albert Michallon

La Tronche, , France

CHU de Limoges Hopital Dupuytren

Limoges, , France

Hopital Edouard Herriot - CHU Lyon

Lyon, , France

Hopital Nord Marseille

Marseille, , France

CHU Nantes - Hotel Dieu

Nantes, , France

CHU De Nice Hopital De l'Archet

Nice, , France

Hôpital Bichat - Claude Bernard

Paris, , France

Hopital Saint Louis

Paris, , France

Hopital Cochin

Paris, , France

CHU Poitiers - Hopital la Miletrie

Poitiers, , France

CHU Saint Etienne Hopital Nord

Saint-Etienne, , France

Universitaetsklinikum Koelnt

Cologne, , Germany

Klinikum Donaustauf

Donaustauf, , Germany

Universitaetsklinik Erlangen

Erlangen, , Germany

Universitaetsklinikum Giessen und Marburg GmbH

Hessen, , Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, , Germany

Klinikum Weiden

Weiden, , Germany

Veszprem Megyei Tudogyogyintezete

Farkasgyepü, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

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

S. R. Kalla Memorial General Hospital

Jaipur, , India

Eternal Heart Care Centre

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

Sir Ganga Ram Hospital

New Delhi, , India

Fortis Flight Lieutenant Rajan Dhall 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

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

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Ziv Medical Center

Safed, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena

Milan, , Italy

Ospedale San Giuseppe - Fatebenefratelli

Milan, , Italy

Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro

Milan, , Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, , 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, , Italy

Regional Hospital of Liepaja

Liepāja, , Latvia

Hospital of Rezekne

Rēzekne, , Latvia

Children's Clinical University Hospital

Riga, , Latvia

Riga East Clinical University Hospital

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Centre of Tuberculosis and Lung Diseases

Riga District, , Latvia

Vidzemes Hospital

Valmiera, , Latvia

Klaipeda University Hospital

Klaipėda, , Lithuania

Siauliai Republican Hospital, Public Institution

Šiauliai, , Lithuania

Infectious Diseases Center of Vilnius University Hospital Santaros klinikos

Vilnius, , Lithuania

Hospital Sultanah Bahiyah

Alor Star, , 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, , Malaysia

JM Research, SC

Cuernavaca, , Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

Hospital Civil de Guadalajara Dr. Juan I. Menchaca

Guadalajara, , Mexico

Hospital Infantil de Mexico Federico Gomez

Mexico City, , Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

México, , Mexico

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, , Netherlands

UMC Utrecht

Utrecht, , Netherlands

Gelre Ziekenhuizen Zutphen

Zutphen, , Netherlands

Christchurch Hospital

Christchurch, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Tauranga Hospital

Tauranga, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Clinica Peruano Americana S.A

Trujillo, , Peru

Szpital Miejski ZOZ

Dębica, , Poland

NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, , Poland

Centrum Medyczne w Lancucie Sp.z o.o.

Łańcut, , Poland

City Hospital #8

Chelyabinsk, , Russia

Clinical Infectious Diseases Hospital n. a. S.P. Botkin

Saint Petersburg, , Russia

Clinical Infectious Diseases Hospital n. a. S.P. Botkin

Saint Petersburg, , Russia

LLC Reafarm

Stavropol, , Russia

Clinical Hospital #3

Yaroslavl, , Russia

National University Hospital

Singapore, , Singapore

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

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.,

Svidník, , Slovakia

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, , South Africa

Chungbuk National University Hospital

Cheongju-si, , South Korea

Yonsei University Wonju Severance Christian Hospital

Gangwon-do, , South Korea

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

The Catholic university of Korea, St. Vincent's Hospital

Gyeonggi-do, , South Korea

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, , South Korea

Gachon University Gil Medical Center

Incheon, , South Korea

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

Incheon, , South Korea

Dong-A University Hospital

Pusan, , South Korea

Korea University Anam Hospital

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Hosp Clinic 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. Univ. de La Princesa

Madrid, , Spain

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp. Clinico San Carlos

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Hm Monteprincipe

Madrid, , Spain

Hosp. De Mataro

Mataró, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Mutua Terrassa

Terrassa, , Spain

Hosp. Alvaro Cunqueiro

Vigo, , Spain

Department for Heart Failure and Valvular Disease

Malmo, , Sweden

Norrlands Universitetssjukhus

Umeå, , Sweden

Akademiska Sjukhuset

Uppsala, , Sweden

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Taipei Medical University-Wan Fang Hospital

Taipei, , Taiwan

Siriraj Hospital

Bangkok, , Thailand

Bamrasnaradura Infectious Disease Institute

Muang, , Thailand

Srinagarind Hospital

Muang, , Thailand

Bumrungrad Hospital

Wattana, , Thailand

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Adnan Menderes University

Aydin, , Turkey (Türkiye)

Dicle University Medical Faculty

Diyarbakır, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Hacettepe University Medical Faculty

Samanpazarı, , Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

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, , Ukraine

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 Kingdom

Bach Mai Hospital

Hanoi, , Vietnam

National Hospital for Tropical Diseases

Hanoi, , Vietnam

Thanh Nhan Hospital

Hanoi, , Vietnam

Children's Hospital 1

Ho Chi Minh City, , Vietnam

Children's Hospital 2

Ho Chi Minh City, , Vietnam

Nguyen Tri Phuong Hospital

Ho Chi Minh City, , Vietnam

Countries

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

References

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)

Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.

Reference Type: DERIVED

PMID: 33248473 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-002156-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

63623872FLZ3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108399

Identifier Type: -

Identifier Source: org_study_id