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A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MHAA4549A
Oseltamivir
Placebo
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of influenza A where a Sponsor-approved influenza test is used as an aid in diagnosis. A Sponsor-approved influenza test includes: Influenza antigen test or Influenza polymerase chain reaction (PCR) test
  • One of the following markers of severity within 24 hours of admission: requirement for O2 supplementation to maintain SpO2 greater than (>) 92 %; or requirement for Positive Pressure Ventilation (PPV)
  • A negative urine or serum pregnancy test for women of childbearing potential within 2 days prior to study treatment
  • Participants of reproductive potential must agree to use acceptable contraceptive measures as per the protocol as a minimum, and local guidelines, if more stringent

Exclusion Criteria:

  • Pregnant or lactating women, or women who intend to become pregnant during the study
  • Hypersensitivity to monoclonal antibodies or any constituents (sodium succinate, sucrose, polysorbate 20) of study drug
  • Hypersensitivity to the active substance or to any excipients of oseltamivir
  • Investigational therapy within the 30 days prior to study treatment
  • Received prior therapy with any anti-influenza monoclonal antibody therapy (including MHAA4549A) within 8 months prior to study treatment
  • Current treatment (within 7 days of dosing) with probenecid, amantadine or rimantidine
  • Participants who have taken more than a total of 6 doses (3 doses for peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir, laninamivir, peramivir) in the period from onset of symptoms and prior to study treatment
  • Admission >48 hours prior to study treatment
  • Onset of influenza symptoms (including fever, chills, malaise, dry cough, loss of appetite, myalgias, coryza, or nausea) >5 days prior to study treatment
  • Positive influenza B or influenza A + B infection within 2 weeks prior to study treatment
  • High probability of mortality in the next 48 hours as determined by the investigator
  • Participants requiring home or baseline oxygenation therapy
  • Participants with history of chronic lung disease with a documented SpO2 less than (<) 95% off oxygen
  • Participants on chronic dose of corticosteroids exceeding 10 milligrams per day (mg/day) of prednisone or equivalent steroid dose for duration of greater than 14 days within 30 days of entry into study
  • Participants with the following significant immune suppression: bone marrow or solid organ transplant in the previous 12 months; cancer chemotherapy in the previous 12 months, HIV infection with most recent Cluster of Differentiation 4 (CD4) <200 cells per milliliter (cells/mL), or other significant immune suppression as determined by the investigator in discussion with the Sponsor Medical Monitor
  • Participants on extracorporeal membrane oxygenation (ECMO) at time of randomization
  • Any disease or condition that would, in the opinion of the site investigator or Sponsor, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Sites / Locations

  • CHU St Pierre (St Pierre)
  • Hospital Erasme; Neurologie
  • UZ Leuven Gasthuisberg
  • CHU UCL Mont-Godinne
  • Santa Casa de Misericordia; de Belo Horizonte
  • Hospital Sao Vicente de Paulo
  • PUC Campinas
  • FUNFARME
  • Hospital Alemao Oswaldo Cruz; Oncologia
  • Hospital Edmundo Vasconcelos
  • MHAT "Dr. Tota Venkova"- Gabrovo
  • University Multiprofile Hospital for Active Treatment "St. George"
  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
  • Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD
  • MHAT Lyulin EAD, Department of internal diseases
  • MHAT TOKUDA SOFIA/ICU-Intensive Care Unit
  • 5th Multifunctional Hospital for Active treatment
  • Military Medical Academy- MHAT
  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
  • MBAL St Marina Dep Pulmonology, ICU
  • Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD
  • Peter Lougheed Centre
  • Alberta Health Services
  • Foothills Medical Centre
  • Rockyview General Hospital
  • Royal Columbian Hospital
  • St. Paul's Hospital, Providence Health Care
  • Victoria General Hospital
  • Royal Jubilee Hospital Victoria general Hospital
  • Moncton Hospital
  • LHSC - University Hospital; Research Pharmacy
  • Lakeridge Health
  • Ottawa Hospital Research Institute
  • The Ottawa Hospital - Civic Campus
  • Toronto East General
  • University Health Network
  • Toronto Western Hospital
  • Centre Hospitalier de la Universite Laval
  • Pavillion Chul-Chuq
  • Centre de santé et de services sociaux de Trois-Rivières
  • Hospital Dr. Hernan Henriquez Aravena
  • Clinica Renaca
  • The University Hospital Brno
  • Fakultni nemocnice Hradec Kralove
  • Anesthesia and Intensive Care Dept., Regional Hospital Liberec
  • University hospital Ostrava, Clinic of infectious medicine
  • Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace
  • CH Victor Dupouy
  • Centre Hospitalier Universitaire de Clermont Ferrand
  • Service de Réanimation médicale - Bocage Central
  • APHP Raymond Poincare
  • CHD Vendée
  • CHRU Lille
  • Réanimation Polyvalente, CHU Limoges
  • CHRU Nancy
  • Archet 1 university Hospital
  • HOPITAL COCHIN university hospital
  • Réanimation médicale NHC
  • Hopital Universitaire Hautepierre
  • Service de réanimation médicale, Hôpital Bretonneau
  • Universitätsklinikum Frankfurt Goethe Universität
  • Universitätsklinikum Heidelberg
  • Uniklinik Köln, Medizinischen Klinik I
  • Uniklinikum Mainz
  • Uniklinik Tübingen
  • University of Hong Kong
  • Pest Megyei Flor Ferenc Korhaz
  • Csolnoky Ferenc Kórház
  • Jávorszky Ödön Hospital
  • Zala County Hospital ICU
  • Haemek Medical Center
  • Soroka University Medical Centre
  • Wolfson Medical Center
  • Hadasit Medical Research Services and Development Ltd
  • Galilee Medical Center
  • Nazareth EMMS Hospital
  • Rabin Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Chaim Sheba Medical Center
  • Ziv Medical Center
  • University Division of Infective and Tropical Diseases, University of Brescia, Italy
  • Clinic of Infectious Diseases
  • University Hospital Modena, Intensive Care Unit
  • National Institute for Infectious Diseases "L. Spallanzani"
  • Asst Di Cremona
  • Ospedale San Raffaele - Milano
  • A.O.U. S. Giovanni di Dio e Ruggi d'Aragona
  • Pusan National University Hospital
  • Gachon University Gil Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Yonsei University Health System/Severance Hospital
  • Hallym university Kangnam Sacred Heart Hospital; Infectious devision
  • Wonju Severance Christian Hospital
  • Hospital Civil de Guadalajara Dr Juan I Menchaca
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
  • CEPREP; Hospital Universitario
  • Hospital General de Tijuana
  • Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio
  • Jeroen Bosch Ziekenhuis
  • Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy
  • LUMC
  • UMC Radboud Nijmegen
  • Erasmus Medical Centre; Department of Virology L-359
  • Ikazia Hospital
  • UMCU
  • Isala
  • Auckland City Hospital
  • Christchurch Hospital
  • Tauranga Hospital
  • Hospital Regional del Cusco
  • Hospital Nacional Adolfo Guevara Velasco
  • Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen
  • Clinica Internacional Sede Lima
  • Hospital Nacional; Arzobispo Loayza
  • Hospital Nacional Hipolito; Unanue
  • Hospital Central Fuerza; Aerea del Peru
  • Hospital Maria Auxiliadora
  • Clínica San Gabriel
  • Clinica San Borja
  • Hospital de la Amistad Peru Corea II-2 Santa Rosa
  • Clinica Divino Nino Jesus; Orden de Malta
  • Clinica Peruana Americana
  • Wojewodzki Szpital Specjalistyczny
  • Icu Spsk - 2
  • Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera
  • Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk
  • Municipal Clinical Hospital #8
  • Municipal Healthcare Institution "City Hospital №2"
  • Medical Military Academy n.a S.M.Kirov
  • Paciific state medical university
  • Milpark Hospital
  • Emmed Research
  • Clinical Projects Research
  • Mutua de Terrassa
  • Hospital Clinic
  • Hospital de Mataro
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Son Espases
  • Hospital del Mar
  • Hospital Universitari Vall d'Hebron
  • Bellvitge University Hospital
  • Hospital Universitario San Cecilio
  • Hosp. Clinico San Carlos
  • Hospital Univ. de Getafe.Servicio de Neurologia
  • Joan XXIII University Hospital
  • Servicio de Medicina Intensiva Hospital Universitario la Fe
  • Sahlgrenska Universitetssjukhuset
  • Uppsala University Hospital, Department of Infectious Diseases
  • Skånes Universitetssjukhus
  • Norrland Universitetssjukhus
  • Kaohsiung Medical University Hospital, Cancer Center
  • Far East Memorial Hospital
  • Wanfang Hospital
  • Chang Gung Medical Foundation Linkou Branch
  • Kyiv City Clinical Hospital #4
  • Kyiv City Clinical Hospital #9
  • Municipal Institution City Clinical Infectious Diseases Hospital
  • Poltava Regional Clinical Infectious Hospital
  • Municipal Institution Central City Hospital #1 City of Zhytomyr
  • Queen Elizabeth Hospital
  • Heart of England NHS Trust
  • Queen Elizabeth University Hospital
  • Leeds General Infirmary, Anaesthetic Department, D Floor
  • King College Hospital NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Southampton University Hospitals NHS Trust
  • University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
  • Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A: MHAA4549A 3600 mg + Oseltamivir

B: MHAA4549A 8400 mg + Oseltamivir

C: Placebo + Oseltamivir

Arm Description

Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.

Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A
Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.
Time to Normalization of Respiratory Function
The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.

Secondary Outcome Measures

Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome
The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.
Percentage of Participants With Clinical Failure
Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2-6 liters per minute [L/min]) to high flow oxygen (i.e., > 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by > 2 weeks, or death.
Percentage of Participants With Clinical Resolution of Abnormal Vital Signs
Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate < 24 breaths per minute without supplemental O2; 3. Core temperature < 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature > 36 C in participants who are initially hypothermic; 4. Heart rate (HR) < 100 beats/minute; 5. Systolic blood pressure (SBP) >90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.
Percentage of Participants Who Died Due to Any Cause
Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus
Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).
Peak Influenza A Viral Load
Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.
Duration of Viral Shedding
Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.
Duration of Hospitalization
Duration of Intensive Care Unit (ICU) Stay
Percentage of Participants Using Antibiotics for Respiratory Infections
Percentage of Participants With Secondary Complications of Influenza
The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.
Percentage of Participants Readmitted to Hospital Due to Any Cause
Duration of Ventilation
Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A
AUC0-inf is reported as day*microgram/milliliter (day*mcg/mL).
Maximum Serum Concentration (Cmax ) of MHAA4549A
Elimination Half-Life (Terminal t1/2) of MHAA4549A
Observed Clearance (CL-obs) of MHAA4549A
Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A

Full Information

First Posted
November 14, 2014
Last Updated
May 18, 2018
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02293863
Brief Title
A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 14, 2015 (Actual)
Primary Completion Date
May 23, 2017 (Actual)
Study Completion Date
May 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: MHAA4549A 3600 mg + Oseltamivir
Arm Type
Experimental
Arm Description
Participants will receive a single low IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
Arm Title
B: MHAA4549A 8400 mg + Oseltamivir
Arm Type
Experimental
Arm Description
Participants will receive a single high IV dose of MHAA4549A on Day 1 and standard oseltamivir therapy for minimum of 5 days.
Arm Title
C: Placebo + Oseltamivir
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1 and standard oseltamivir therapy (75 or 150 mg BID) for minimum of 5 days.
Intervention Type
Drug
Intervention Name(s)
MHAA4549A
Intervention Description
Participants will receive a single dose of MHAA4549A by IV infusion on Day 1
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Other Intervention Name(s)
Tamiflu
Intervention Description
Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
From randomization up to 60 days
Title
Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A
Description
Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.
Time Frame
From randomization up to 60 days
Title
Time to Normalization of Respiratory Function
Description
The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.
Time Frame
From randomization up to 60 days
Secondary Outcome Measure Information:
Title
Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome
Description
The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.
Time Frame
Days 1-7, 14 and 30
Title
Percentage of Participants With Clinical Failure
Description
Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2-6 liters per minute [L/min]) to high flow oxygen (i.e., > 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by > 2 weeks, or death.
Time Frame
24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60
Title
Percentage of Participants With Clinical Resolution of Abnormal Vital Signs
Description
Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate < 24 breaths per minute without supplemental O2; 3. Core temperature < 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature > 36 C in participants who are initially hypothermic; 4. Heart rate (HR) < 100 beats/minute; 5. Systolic blood pressure (SBP) >90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.
Time Frame
From randomization up to 60 days
Title
Percentage of Participants Who Died Due to Any Cause
Time Frame
Days 14, 30 and 60
Title
Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus
Description
Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).
Time Frame
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Title
Peak Influenza A Viral Load
Description
Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.
Time Frame
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Title
Duration of Viral Shedding
Description
Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.
Time Frame
Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)
Title
Duration of Hospitalization
Time Frame
From randomization up to 60 days
Title
Duration of Intensive Care Unit (ICU) Stay
Time Frame
From randomization up to 60 days
Title
Percentage of Participants Using Antibiotics for Respiratory Infections
Time Frame
From randomization up to 60 days
Title
Percentage of Participants With Secondary Complications of Influenza
Description
The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.
Time Frame
From randomization up to 60 days
Title
Percentage of Participants Readmitted to Hospital Due to Any Cause
Time Frame
Days 30 and 60
Title
Duration of Ventilation
Time Frame
From randomization up to 60 days
Title
Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A
Description
AUC0-inf is reported as day*microgram/milliliter (day*mcg/mL).
Time Frame
30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Title
Maximum Serum Concentration (Cmax ) of MHAA4549A
Time Frame
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Title
Elimination Half-Life (Terminal t1/2) of MHAA4549A
Time Frame
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Title
Observed Clearance (CL-obs) of MHAA4549A
Time Frame
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)
Title
Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A
Time Frame
30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of influenza A where a Sponsor-approved influenza test is used as an aid in diagnosis. A Sponsor-approved influenza test includes: Influenza antigen test or Influenza polymerase chain reaction (PCR) test One of the following markers of severity within 24 hours of admission: requirement for O2 supplementation to maintain SpO2 greater than (>) 92 %; or requirement for Positive Pressure Ventilation (PPV) A negative urine or serum pregnancy test for women of childbearing potential within 2 days prior to study treatment Participants of reproductive potential must agree to use acceptable contraceptive measures as per the protocol as a minimum, and local guidelines, if more stringent Exclusion Criteria: Pregnant or lactating women, or women who intend to become pregnant during the study Hypersensitivity to monoclonal antibodies or any constituents (sodium succinate, sucrose, polysorbate 20) of study drug Hypersensitivity to the active substance or to any excipients of oseltamivir Investigational therapy within the 30 days prior to study treatment Received prior therapy with any anti-influenza monoclonal antibody therapy (including MHAA4549A) within 8 months prior to study treatment Current treatment (within 7 days of dosing) with probenecid, amantadine or rimantidine Participants who have taken more than a total of 6 doses (3 doses for peramivir) of anti-influenza therapy (e.g., oseltamivir, zanamivir, laninamivir, peramivir) in the period from onset of symptoms and prior to study treatment Admission >48 hours prior to study treatment Onset of influenza symptoms (including fever, chills, malaise, dry cough, loss of appetite, myalgias, coryza, or nausea) >5 days prior to study treatment Positive influenza B or influenza A + B infection within 2 weeks prior to study treatment High probability of mortality in the next 48 hours as determined by the investigator Participants requiring home or baseline oxygenation therapy Participants with history of chronic lung disease with a documented SpO2 less than (<) 95% off oxygen Participants on chronic dose of corticosteroids exceeding 10 milligrams per day (mg/day) of prednisone or equivalent steroid dose for duration of greater than 14 days within 30 days of entry into study Participants with the following significant immune suppression: bone marrow or solid organ transplant in the previous 12 months; cancer chemotherapy in the previous 12 months, HIV infection with most recent Cluster of Differentiation 4 (CD4) <200 cells per milliliter (cells/mL), or other significant immune suppression as determined by the investigator in discussion with the Sponsor Medical Monitor Participants on extracorporeal membrane oxygenation (ECMO) at time of randomization Any disease or condition that would, in the opinion of the site investigator or Sponsor, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
CHU St Pierre (St Pierre)
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hospital Erasme; Neurologie
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
PUC Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
FUNFARME
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-020
Country
Brazil
Facility Name
Hospital Edmundo Vasconcelos
City
Vila Clementino
State/Province
SP
ZIP/Postal Code
04038-905
Country
Brazil
Facility Name
MHAT "Dr. Tota Venkova"- Gabrovo
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "St. George"
City
Plovdiv
ZIP/Postal Code
4005
Country
Bulgaria
Facility Name
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
MHAT Lyulin EAD, Department of internal diseases
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
MHAT TOKUDA SOFIA/ICU-Intensive Care Unit
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
5th Multifunctional Hospital for Active treatment
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Military Medical Academy- MHAT
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MBAL St Marina Dep Pulmonology, ICU
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
St. Paul's Hospital, Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Victoria General Hospital
City
Victora
State/Province
British Columbia
ZIP/Postal Code
V8Z 6R5
Country
Canada
Facility Name
Royal Jubilee Hospital Victoria general Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
Country
Canada
Facility Name
Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
LHSC - University Hospital; Research Pharmacy
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
The Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Toronto East General
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Centre Hospitalier de la Universite Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pavillion Chul-Chuq
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Centre de santé et de services sociaux de Trois-Rivières
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A1Y1
Country
Canada
Facility Name
Hospital Dr. Hernan Henriquez Aravena
City
Temuco
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Clinica Renaca
City
Vina del Mar
ZIP/Postal Code
2540364
Country
Chile
Facility Name
The University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Anesthesia and Intensive Care Dept., Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
University hospital Ostrava, Clinic of infectious medicine
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
CH Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Centre Hospitalier Universitaire de Clermont Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Service de Réanimation médicale - Bocage Central
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
APHP Raymond Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Réanimation Polyvalente, CHU Limoges
City
Limoges
ZIP/Postal Code
87043
Country
France
Facility Name
CHRU Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Archet 1 university Hospital
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
HOPITAL COCHIN university hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Réanimation médicale NHC
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Hopital Universitaire Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de réanimation médicale, Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitätsklinikum Frankfurt Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Uniklinik Köln, Medizinischen Klinik I
City
Koeln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Uniklinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Uniklinik Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2084
Country
Hungary
Facility Name
Csolnoky Ferenc Kórház
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Jávorszky Ödön Hospital
City
Vác
ZIP/Postal Code
2600
Country
Hungary
Facility Name
Zala County Hospital ICU
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Soroka University Medical Centre
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Hadasit Medical Research Services and Development Ltd
City
Jerusalem
ZIP/Postal Code
91999
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Nazareth EMMS Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7661041
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52661
Country
Israel
Facility Name
Ziv Medical Center
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
Facility Name
University Division of Infective and Tropical Diseases, University of Brescia, Italy
City
Brescia
State/Province
Basilicata
Country
Italy
Facility Name
Clinic of Infectious Diseases
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40127
Country
Italy
Facility Name
University Hospital Modena, Intensive Care Unit
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41125
Country
Italy
Facility Name
National Institute for Infectious Diseases "L. Spallanzani"
City
Rome
State/Province
Lazio
ZIP/Postal Code
149
Country
Italy
Facility Name
Asst Di Cremona
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale San Raffaele - Milano
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
A.O.U. S. Giovanni di Dio e Ruggi d'Aragona
City
Salerno
State/Province
Sardegna
ZIP/Postal Code
84131
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Yonsei University Health System/Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Hallym university Kangnam Sacred Heart Hospital; Infectious devision
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Hospital Civil de Guadalajara Dr Juan I Menchaca
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
City
Mexico, Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
CEPREP; Hospital Universitario
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital General de Tijuana
City
Tijuana
ZIP/Postal Code
22320
Country
Mexico
Facility Name
Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio
City
Xalapa-enriquez
ZIP/Postal Code
91020
Country
Mexico
Facility Name
Jeroen Bosch Ziekenhuis
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy
City
Apeldoorn
ZIP/Postal Code
7334 DV
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2300 ZA
Country
Netherlands
Facility Name
UMC Radboud Nijmegen
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Erasmus Medical Centre; Department of Virology L-359
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Ikazia Hospital
City
Rotterdam
ZIP/Postal Code
3083AN
Country
Netherlands
Facility Name
UMCU
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Isala
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1124
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Hospital Regional del Cusco
City
Cusco
ZIP/Postal Code
84
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco
City
Cuzco
ZIP/Postal Code
84
Country
Peru
Facility Name
Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen
City
La Victoria
ZIP/Postal Code
Lima 13
Country
Peru
Facility Name
Clinica Internacional Sede Lima
City
LIma
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Hospital Nacional; Arzobispo Loayza
City
LIma
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Hospital Nacional Hipolito; Unanue
City
Lima
ZIP/Postal Code
Lima 10
Country
Peru
Facility Name
Hospital Central Fuerza; Aerea del Peru
City
Lima
ZIP/Postal Code
Lima 18
Country
Peru
Facility Name
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
Clínica San Gabriel
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Facility Name
Clinica San Borja
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
Facility Name
Hospital de la Amistad Peru Corea II-2 Santa Rosa
City
Piura
ZIP/Postal Code
20001
Country
Peru
Facility Name
Clinica Divino Nino Jesus; Orden de Malta
City
San Juan de Miraflores
ZIP/Postal Code
LIMA 29
Country
Peru
Facility Name
Clinica Peruana Americana
City
Trujillo
ZIP/Postal Code
13011
Country
Peru
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Icu Spsk - 2
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk
City
Łódź
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Municipal Clinical Hospital #8
City
Chelyabinsk
ZIP/Postal Code
454000
Country
Russian Federation
Facility Name
Municipal Healthcare Institution "City Hospital №2"
City
Engels
ZIP/Postal Code
413124
Country
Russian Federation
Facility Name
Medical Military Academy n.a S.M.Kirov
City
St.Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Paciific state medical university
City
Vladivostok
ZIP/Postal Code
690002
Country
Russian Federation
Facility Name
Milpark Hospital
City
Parktown West
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Clinical Projects Research
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Cantabria
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Mataro
City
Mataro
State/Province
Cantabria
ZIP/Postal Code
08304
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Bellvitge University Hospital
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Univ. de Getafe.Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Joan XXIII University Hospital
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Servicio de Medicina Intensiva Hospital Universitario la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Uppsala University Hospital, Department of Infectious Diseases
City
Göteborg
ZIP/Postal Code
41650
Country
Sweden
Facility Name
Skånes Universitetssjukhus
City
Mamö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Norrland Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Kaohsiung Medical University Hospital, Cancer Center
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Far East Memorial Hospital
City
New Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Kyiv City Clinical Hospital #4
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #9
City
Kyiv
ZIP/Postal Code
04060
Country
Ukraine
Facility Name
Municipal Institution City Clinical Infectious Diseases Hospital
City
Odesa
ZIP/Postal Code
65023
Country
Ukraine
Facility Name
Poltava Regional Clinical Infectious Hospital
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Municipal Institution Central City Hospital #1 City of Zhytomyr
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Heart of England NHS Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Leeds General Infirmary, Anaesthetic Department, D Floor
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
King College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Southampton University Hospitals NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital
City
Stoke-On-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32393496
Citation
Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.
Results Reference
derived

Learn more about this trial

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

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