Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
- Registration Number
- NCT03969212
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 1 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication. Baloxavir Marboxil Baloxavir Marboxil Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
- Primary Outcome Measures
Name Time Method Percentage of HHCs With Virological Influenza Transmission by Day 5 Baseline (Day 1) to Day 5 The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.
- Secondary Outcome Measures
Name Time Method Percentage of HHCs With Symptomatic Influenza Transmission by Day 5 Baseline (Day 1) to Day 5 The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of respective IP, \& developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years old were symptomatic if 1. Presence of temperature ≥38.0 Celsius (C) and 1 respiratory symptom (cough, sore throat, nasal congestion) or 2. Presence of 1 respiratory symptom and 1 general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with/without a fever. HHCs ≥2 and \<12 years old were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory tract infection signs or symptoms (cough, nasal congestion, or rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5 Baseline (Day 1) to Day 5 Percentage of households with at least one HHC who met the primary endpoint of virological transmission by Day 5 are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5 Baseline (Day 1) to Day 5 Percentage of HHs with at least one HHC who meets the symptomatic transmission by Day 5 endpoint are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Percentage of HHCs With Virological Influenza Transmission by Day 9 Baseline (Day 1) to Day 9 The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization with virus subtype matching with the respective IP, irrespective of being symptomatic or asymptomatic including: 1. all HHC meeting primary endpoint, AND 2. all HHC cases detected after Day 5 meeting the following criteria: 2a. included HHC case was in an HH where another HHC had already met the primary endpoint OR 2b. included HHC case was PCR+ bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein (PA/I38X substitution) or amino acid substitution of threonine to lysine at position 20 in the PA protein for influenza B only (PA/T20K). The adjusted incidence rates presented were estimated using a GEE approach.
Percentage of HHCs With Symptomatic Influenza Transmission by Day 9 Baseline (Day 1) to Day 9 The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological transmission by Day 9 endpoint and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had 1. temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or 2. one respiratory and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (headache, feverishness or chills, muscle or joint pain, fatigue). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Percentage of HHCs With Any Virological Infection by Day 9 Baseline (Day 1) to Day 9 Virological infection was defined as HHCs who tested PCR+ for influenza by Day 9 post IP randomization based on PCR influenza test results. The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological infection by Day 9 endpoint. The adjusted incidence rates presented were estimated using a GEE approach.
Percentage of HHs With Any Virological Infection at HH Level by Day 9 Baseline (Day 1) to Day 9 Virological infection at the HH level was defined as the HHs with at least one HHC who met the endpoint of any virological infection by Day 9. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Percentage of HHCs With Any Symptomatic Infection by Day 9 Baseline (Day 1) to Day 9 The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had (1) a temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or (2) one respiratory and one systemic symptom (headache, chills, muscle/joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.
Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9 Baseline (Day 1) to Day 9 Percentage of HHs with at least one HHC who meets the endpoint of any symptomatic infection by Day 9 are reported here. HHCs ≥12 years were symptomatic if they had 1. a temperature ≥38.0°C \&1 respiratory symptom (cough, sore throat, nasal congestion) or 2. 1 respiratory \& 1 systemic symptom (headache, chills, muscle/joint pain, fatigue), with/without fever. HHCs ≥2 \& \<12 years were symptomatic if the temperature was ≥38.0°C \& had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be new or have worsened versus baseline in HHC with baseline symptoms due to preexisting comorbidity. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.
Number of IPs With Adverse Events (AEs) Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old) An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Number of IPs With Serious Adverse Events (SAEs) Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old) A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Trial Locations
- Locations (137)
Medical corporation Seijinkai Takei Clinic
🇯🇵Tsuru, Japan
Gushiken-Cardiology and Internal medicine
🇯🇵Urasoe, Japan
Uranishi Clinic
🇯🇵Urasoe, Japan
Yotsukaido Tokushukai Medical Center
🇯🇵Yotsukaido, Japan
Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States
Cahaba Research, Inc
🇺🇸Pelham, Alabama, United States
Precision Trials
🇺🇸Phoenix, Arizona, United States
South Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Cordova Research Institute, LLC
🇺🇸Miami, Florida, United States
Research Institute of South Florida Inc
🇺🇸Miami, Florida, United States
Burke Primary Care
🇺🇸Morganton, North Carolina, United States
Pioneer Research Solutions
🇺🇸Houston, Texas, United States
ICIMED Instituto de Investigación en Ciencias Médicas
🇨🇷San José, Costa Rica
Laiko General Hospital - Uni of Athens
🇬🇷Athens, Greece
Sotiria General Hospital of Athens
🇬🇷Athens, Greece
Attikon University General Hospital
🇬🇷Chaidari, Greece
Obudai Egeszsegugyi Centrum Kft.
🇭🇺Budapest, Hungary
II. Háziorvosi Körzet
🇭🇺Hosszúhetény, Hungary
Gyermekháziorvosi rendel?- Dr. Újhelyi János
🇭🇺Nyíregyháza, Hungary
OEC Clinical Research
🇭🇺Zalaegerszeg, Hungary
JSS Hospital
🇮🇳Mysuru, Karnataka, India
Kiryat Motzkin Maccabi Medical Center
🇮🇱Kiryat Motzkin, Israel
Maccabi health services - Moked Hashalom
🇮🇱Tel Aviv, Israel
Toda Internal Medicine & Neurology Clinic
🇯🇵Akashi, Japan
Medical Corporation Houmankai?Umezu?Clinic
🇯🇵Chikushino, Japan
Shin Komonji Hospital
🇯🇵Fukuoka, Japan
Irie Naika Syounika Iin
🇯🇵Fukuoka, Japan
Kimura Siro Clinic
🇯🇵Fukuoka, Japan
Iguchi Clinic
🇯🇵Fukuyama, Japan
Mashiba Clinic
🇯🇵Hanno, Japan
Fujimaki Ent Clinic
🇯🇵Ichikawa, Japan
Hisaki Family Clinic
🇯🇵Ichikawa, Japan
Moriyama Otolaryngology
🇯🇵Kagoshima, Japan
Kamoike ENT Allergy Clinic
🇯🇵Kagoshima, Japan
Clinic Kashiwanoha
🇯🇵Kashiwa, Japan
Kamezawa Clinic
🇯🇵Kasugai, Japan
Oishi Clinic
🇯🇵Kasuyagun, Japan
Takahashi naika
🇯🇵Kawasaki, Japan
Kanagawa Himawari Clinic
🇯🇵Kawasaki, Japan
Osaki Internal and Respiratory Clinic,
🇯🇵Kitakyushu, Japan
Morizono medical clinic
🇯🇵Kitakyushu, Japan
Sato ENT Clinic
🇯🇵Kitakyushu, Japan
Kiheibashi Otolaryngology
🇯🇵Kodaira, Japan
Medical corporation Shirayurikai Swing Nozaki Clinic
🇯🇵Musashino, Japan
Yaesu Clinic
🇯🇵Naha, Japan
Horikawa Clinic
🇯🇵Nonoichi, Japan
Funai Ear Nose Throat Clinic
🇯🇵Oita, Japan
Lee's Clinic
🇯🇵Osaka, Japan
Kitada Clinic
🇯🇵Osaka, Japan
Sunami Internal medicine Clinic
🇯🇵Osaka, Japan
Saga Memorial Hospital
🇯🇵Saga, Japan
Segawa Hospital
🇯🇵Saitama, Japan
Uehara Clinic
🇯🇵Sapporo, Japan
Aiiku Hospital
🇯🇵Sapporo, Japan
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
🇯🇵Shinagawa, Japan
Wakasa Clinic
🇯🇵Tokorozawa, Japan
Seiwa Clinic
🇯🇵Tokyo, Japan
Denenchofu Family Clinic
🇯🇵Tokyo, Japan
Sato Clinic
🇯🇵Tokyo, Japan
Sekino Hospital
🇯🇵Toshima, Japan
Takeru CLINIC
🇯🇵Toyohashi, Japan
Tsuchiura Beryl Clinic
🇯🇵Tsuchiura, Japan
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
🇹🇷Istanbul, Turkey
Dokuz Eylul University Medical Faculty
🇹🇷Izmir, Turkey
Kocaeli University Medical Faculty
🇹🇷Kocaeli, Turkey
Preston Hill Surgery
🇬🇧Harrow, United Kingdom
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Vilo Research Group
🇺🇸Houston, Texas, United States
Mercury Clinical Research
🇺🇸Houston, Texas, United States
Fairway Medical Clinic
🇺🇸Houston, Texas, United States
Capital Medical University Beijing Hospital of Traditional Chinese Medicine
🇨🇳Beijing City, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing City, China
Beijing Ditan Hospital
🇨🇳Beijing, China
Beijing You An Hospital
🇨🇳Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
The Third People's Hospital of Hainan Province
🇨🇳Sansha City, China
Shenzhen children's hospital
🇨🇳Shenzhen City, China
Shenzhen People's Hospital
🇨🇳Shenzhen, China
Taizhou People's Hospital
🇨🇳Taizhou City, China
The First Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, China
Ankara University Faculty of Medicine Cebeci Hospital
🇹🇷Ankara, Turkey
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Jedda Enterprises dba Galen Clinical Research
🇺🇸Greer, South Carolina, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Downtown LA Research Center
🇺🇸Los Angeles, California, United States
Probe Clinical Research
🇺🇸Riverside, California, United States
MD Strategies Research Centers
🇺🇸San Diego, California, United States
Cherry Creek Family Practice
🇺🇸Denver, Colorado, United States
Proactive Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Helios Clinical Research, Inc (former Ventavia Research Group)
🇺🇸Kissimmee, Florida, United States
Kendall South Medical Center Inc.
🇺🇸South Miami, Florida, United States
Agile Clinical Research Trials
🇺🇸Atlanta, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Mishawaka Osteopathic Clinic
🇺🇸Mishawaka, Indiana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Montana Medical Research LLC
🇺🇸Missoula, Montana, United States
Accent Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
OnSite Clinical Solutions LLC
🇺🇸Charlotte, North Carolina, United States
Hometown Urgent Care and Occupational Health - Springdale
🇺🇸Cincinnati, Ohio, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Frontier Clinical Research
🇺🇸Kingwood, West Virginia, United States
AFC Urgent Care-Gunbarrell
🇺🇸Chattanooga, Tennessee, United States
City Doc Urgent Care-Dallas/Ft. Worth
🇺🇸Dallas, Texas, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Premier Pulmonary Critical Care and Sleep Medicine
🇺🇸Denison, Texas, United States
Family Practice Center
🇺🇸McAllen, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Medical Centre "Asklepii", OOD
🇧🇬Dupnitsa, Bulgaria
Medical Center Hera Eood
🇧🇬Montana, Bulgaria
MHAT Sveta Paraskeva
🇧🇬Pleven, Bulgaria
Medizinski Zentrar-1-Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
MHAT Sliven - Military Medial Academy
🇧🇬Sliven, Bulgaria
Medical Center Hera Sofia
🇧🇬Sofia, Bulgaria
MHAT Sveta Sofia
🇧🇬Sofia, Bulgaria
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Centro Respiratorio de México
🇲🇽Mexico, Mexico CITY (federal District), Mexico
Centro de Estudios Clinicos de Queretaro (CECLIQ)
🇲🇽Querétaro, Queretaro, Mexico
EME RED
🇲🇽Mérida, Yucatan, Mexico
Merida | Investigacion Clinica
🇲🇽Mérida, Yucatan, Mexico
KLIMED
🇵🇱Bia?ystok, Poland
Centrum Medyczne Lukamed Joanna Luka
🇵🇱Chojnice, Poland
KO-MED Centra Kliniczne Sp. z o.o.
🇵🇱Pu?awy, Poland
CLINHOUSE Sp z o.o.
🇵🇱Zabrze, Poland
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Into Research
🇿🇦Groenkloof, South Africa
Newtown Clinical Research
🇿🇦Johannesburg, South Africa
Langeberg Clinical Trials
🇿🇦Kraaifontein, South Africa
Midrand Medical Centre
🇿🇦Midrand, South Africa
Centro de Salud Las Aguilas
🇪🇸Madrid, Spain
Ankara Bilkent City Hospital
🇹🇷Ankara, Turkey