Clinical trial NCT03376321: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza A
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 334
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Hospital Recovery Scale on Day 6
timeFrame: Day 6
Secondary outcomes:
measure: Time to Hospital Discharge
timeFrame: Up to Day 33
measure: Number of Participants With Adjudicated Influenza Complications
timeFrame: Up to Day 33
measure: Viral Load Over Time
timeFrame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Day 33
measure: Number of Participants With Emergence of Viral Resistance to Pimodivir
timeFrame: Up to Day 33
measure: Plasma Concentration of Pimodivir
timeFrame: 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
measure: Number of Participants With Clinically Significant Changes in Laboratory Tests
timeFrame: Up to Day 33
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
timeFrame: Up to Day 33
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Up to Day 33
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Jonesboro
country: United States
facility: Nea Baptist Clinic
state: Arkansas
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Long Beach
country: United States
facility: Miller Children's at Long Beach Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Santa Rosa Beach
country: United States
facility: Destin Pulmonary Critical Care, PLLS.
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University Of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State Univ School of Medicine
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Regents of the University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Newark
country: United States
facility: Saint Michaels Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center PRIME
state: New York
city: Cincinnati
country: United States
facility: UC Health LLC
state: Ohio
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Lowcountry Infectious Diseases
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Bahia Blanca
country: Argentina
facility: Hospital Interzonal General de Agudos Dr. Jose Penna
city: C.a.b.a.
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
city: Cordoba
country: Argentina
facility: Hospital Nuestra Señora de la Misericordia
city: Cordoba
country: Argentina
facility: Hospital Cordoba
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Córdoba
country: Argentina
facility: Hospital Rawson
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: General Roca
country: Argentina
facility: Sanatorio Juan XXIII
city: La Plata Lpl Lpl
country: Argentina
facility: Hospital Italiano de La Plata
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Rosario
country: Argentina
facility: Sanatorio Britanico S.A.
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Box Hill
country: Australia
facility: Box Hill Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Townsville
country: Australia
facility: Townsville Hospital
city: Wien
country: Austria
facility: AKH - Medizinische Universitat Wien
city: Wien
country: Austria
facility: SMZ Süd - Kaiser Franz Josef Spital Wien
city: Wien
country: Austria
facility: Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital
city: Brussel
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Bruxelles
country: Belgium
facility: ULB Hôpital Erasme
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Belo Horizonte
country: Brazil
facility: Cardresearch - Cardiologia Assistencial
city: Brasil
country: Brazil
facility: Infection Control Ltda
city: Passo Fundo
country: Brazil
facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Jose Luiz Egydio Setubal
city: Sao Paulo
country: Brazil
facility: Hosp. Da Luz Lisboa
city: Ruse
country: Bulgaria
facility: SHATPPD - Ruse Ltd.
city: Sofia
country: Bulgaria
facility: SHATPPD - Sofia District EOOD
city: Sofia
country: Bulgaria
facility: Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
city: Sofia
country: Bulgaria
facility: Military Medical Academy - Sofia
city: Veliko Tarnovo
country: Bulgaria
facility: MHAT Dr Stefan Cherkezov
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Sudbury
country: Canada
facility: Health Sciences North Horizon Sante-Nord
state: Ontario
city: Puente Alto
country: Chile
facility: Hospital Dr Sotero del Rio
city: San Bernardo
country: Chile
facility: Hospital El Pino
city: Changsha
country: China
facility: The Third Xiangya Hospital, Central South University
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Wuxi
country: China
facility: Wuxi People s Hospital
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, p.o.
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Agen cedex 9
country: France
facility: Centre Hospitalier d'Agen
city: Amiens Cedex
country: France
facility: CHU Amiens - Hopital Sud
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Creteil cedex
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Dijon
country: France
facility: CHU Dijon
city: La Roche S/ Yon Cedex 9
country: France
facility: Centre Hospitalier Départemental
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: Limoges
country: France
facility: CHU de Limoges Hopital Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot - CHU Lyon
city: Marseille cedex 20
country: France
facility: Hopital Nord Marseille
city: NANTES Cedex 01
country: France
facility: CHU Nantes - Hotel Dieu
city: Nantes Cedex 1
country: France
facility: CHU Nantes - Hotel Dieu
city: Nice Cedex 3
country: France
facility: CHU De Nice Hopital De l'Archet
city: Paris cedex 10
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hôpital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital Cochin
city: Poitiers
country: France
facility: CHU Poitiers - Hopital la Miletrie
city: Saint-Etienne Cedex 2
country: France
facility: CHU Saint Etienne Hopital Nord
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Erlangen
country: Germany
facility: Universitaetsklinik Erlangen
city: Hessen
country: Germany
facility: Universitaetsklinikum Giessen und Marburg GmbH
city: Koeln
country: Germany
facility: Universitaetsklinikum Koelnt
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
city: Weiden
country: Germany
facility: Klinikum Weiden
city: Farkasgyepü
country: Hungary
facility: Veszprem Megyei Tudogyogyintezete
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Ahmedabad
country: India
facility: Zydus Hospital-Ahmedabad
city: Balaga
country: India
facility: Rajiv Gandhi Institute of Medical Sciences
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Gandhinagar
country: India
facility: Apollo Hospitals International Limited
city: Hyderabad
country: India
facility: Aware Global Hospital
city: Jaipur
country: India
facility: S. R. Kalla Memorial General Hospital
city: Jaipur
country: India
facility: Eternal Heart Care Centre
city: Lucknow
country: India
facility: Ajanta Research Cemtre
city: Lucknow
country: India
facility: Midland Healthcare & Research Center
city: Mangalore
country: India
facility: Vinaya Hospital and Research Center
city: Manipal
country: India
facility: Kasturba Medical College Hospital
city: Nagpur
country: India
facility: Suretech Hospital and Research Centre Limited
city: Nashik
country: India
facility: Siddhi Hospital
city: New Delhi
country: India
facility: BLK Super Specialty Hospital
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: New Delhi
country: India
facility: Fortis Flight Lieutenant Rajan Dhall Hospital
city: Pune
country: India
facility: Lifepoint Multispecialty Hospital
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Surat
country: India
facility: BAPS Pramukhswami Hospital
city: Afula
country: Israel
facility: Haemek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beersheba
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospita Ein Kerem
city: Kfar-Saba
country: Israel
facility: Sapir Medical Center, Meir Hospital
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Rechovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena
city: Milano
country: Italy
facility: Ospedale San Giuseppe - Fatebenefratelli
city: Milano
country: Italy
facility: Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: AOU Policlinico di Modena
city: Monza
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
city: Novara
country: Italy
facility: Azienda Ospedaliera Universitaria Maggiore della Carità
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Lazzaro Spallanzani IRCCS
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Liepaja
country: Latvia
facility: Regional Hospital of Liepaja
city: Rezekne
country: Latvia
facility: Hospital of Rezekne
city: Riga District
country: Latvia
facility: Centre of Tuberculosis and Lung Diseases
city: Riga
country: Latvia
facility: Children's Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Siauliai
country: Lithuania
facility: Siauliai Republican Hospital, Public Institution
city: Vilnius
country: Lithuania
facility: Infectious Diseases Center of Vilnius University Hospital Santaros klinikos
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Kuala
country: Malaysia
facility: Hospital Sultanah Nur Zahirah
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
city: Miri
country: Malaysia
facility: Hospital Miri
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar
city: Sibu
country: Malaysia
facility: Hospital Sibu
city: Sungai Buloh
country: Malaysia
facility: Hospital Sungai Buloh
city: Taiping
country: Malaysia
facility: Hospital Taiping
city: Ciudad De Mexico
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
city: Cuernavaca
country: Mexico
facility: JM Research, SC
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca
city: Mexico
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: s-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Zutphen
country: Netherlands
facility: Gelre Ziekenhuizen Zutphen
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Tauranga
country: New Zealand
facility: Tauranga Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Trujillo
country: Peru
facility: Clinica Peruano Americana S.A
city: Debica
country: Poland
facility: Szpital Miejski ZOZ
city: Lancut
country: Poland
facility: Centrum Medyczne w Lancucie Sp.z o.o.
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
city: Chelyabinsk
country: Russian Federation
facility: City Hospital #8
city: Saint-Petersburg
country: Russian Federation
facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin
city: St. Petersburg
country: Russian Federation
facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin
city: Stavropol
country: Russian Federation
facility: LLC Reafarm
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital #3
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bratislava
country: Slovakia
facility: DFNsP Bratislava
city: Malacky
country: Slovakia
facility: Nemocnica Malacky, Nemocnicna A.S.
city: Michalovce
country: Slovakia
facility: Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
city: Svidnik
country: Slovakia
facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
city: Cape Town
country: South Africa
facility: Clinical Research Centre University of Cape Town
city: Centurion
country: South Africa
facility: Johese Unitas
city: Durban
country: South Africa
facility: Abdullah, IA
city: Durban
country: South Africa
facility: Sebastian, Peter
city: Krugersdorp
country: South Africa
facility: DJW Research
city: Pretoria
country: South Africa
facility: Emmed Research
city: Pretoria
country: South Africa
facility: Into Research
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Donostia-San Sebastian
country: Spain
facility: Hosp. Univ. Donostia
city: Elche
country: Spain
facility: Hosp. Gral. Univ. de Elche
city: Getafe
country: Spain
facility: Hosp. Univ. de Getafe
city: Granada
country: Spain
facility: Hosp. Univ. San Cecilio
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: L'Hospitalet de Llobregat
country: Spain
facility: Hosp. Univ. de Bellvitge
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. Hm Monteprincipe
city: Mataro
country: Spain
facility: Hosp. De Mataro
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Terrassa
country: Spain
facility: Hosp. Mutua Terrassa
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Malmö
country: Sweden
facility: Department for Heart Failure and Valvular Disease
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Muang
country: Thailand
facility: Bamrasnaradura Infectious Disease Institute
city: Muang
country: Thailand
facility: Srinagarind Hospital
city: Wattana
country: Thailand
facility: Bumrungrad Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Aydin
country: Turkey
facility: Adnan Menderes University
city: Diyarbakir
country: Turkey
facility: Dicle University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Samanpazari
country: Turkey
facility: Hacettepe University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Teknik University Medical Faculty
city: Kharkiv
country: Ukraine
facility: Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.
city: Kyiv
country: Ukraine
facility: Kyiv Oleksandrivska Clinical Hospital
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
city: Vinnytsia
country: Ukraine
facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
city: Zhytomyr
country: Ukraine
facility: Communal Institution Central City Hospital
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Diseases
city: Hanoi
country: Vietnam
facility: Thanh Nhan Hospital
city: Ho Chi Minh
country: Vietnam
facility: Children's Hospital 1
city: Ho Chi Minh
country: Vietnam
facility: Children's Hospital 2
city: Ho Chi Minh
country: Vietnam
facility: Nguyen Tri Phuong Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.