A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Who is this study for? Patients with Influenza
What treatments are being studied? Baloxavir Marboxil
Status: Completed
Location: See all (142) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 64
Healthy Volunteers: f
View:

⁃ Index Patients (IPs):

• Able to comply with the study protocol per investigator judgment.

• Diagnosed with acute influenza infection by investigator.

• Polymerase chain reaction \[PCR\] (+) or Rapid Influenza Diagnostic Test \[RIDT\] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.

• PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result

• Presence of (a) fever (\>=38.0 °C per tympanic or rectal thermometer; \>=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).

• The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.

• IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) \>=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening.

• Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol

⁃ All HHCs (Part 1):

• PCR (-) or RIDT (-) based on cobas® SARS-CoV-2 and influenza A/B or other local point-of-care / local laboratory result.

• PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B or other POC / local laboratory result.

• HHC lives with no HHC who will be present in the home at any time during the study and who meets any HHC exclusion criteria.

• HHC lives with no HHC who does not meet HHC inclusion criteria (part 1).

• HHC lives in a household where ≥1 HHCs meet all of the following: Start screening within 24 hours after IP randomization; Have NOT received the influenza vaccine within 6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2.

⁃ Full study HHCs (part 2) intended for full study must meet the following additional criteria for study entry:

• Agree to participate in the full study.

• Able to comply with the study protocol per investigator judgment

• No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms are permissible if determined by the investigator to be due to a preexisting condition.

• Temperature \<38.0 °C (tympanic).

• Will reside in the index patient's house for at least 7 of the next 9 days and will be present for scheduled study visits.

• Willing and able to measure and record temperature, or have another household member perform the task on his or her behalf. Furthermore, a responsible adult will assume responsibility to oversee or perform this task on behalf of minors.

• In the 6 months prior to screening: a) Has not been diagnosed with influenza by a healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, favipiravir or amantadine.

• Does not have a moderate or worse active infections OR infections requiring systemic (e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled, intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild external infections allowed).

Locations
United States
Alabama
Cahaba Research, Inc.
Birmingham
Cahaba Research, Inc
Pelham
Arizona
Precision Trials
Phoenix
California
Hope Clinical Research
Canoga Park
Long Beach Clinical Trials
Long Beach
Downtown LA Research Center
Los Angeles
Probe Clinical Research
Riverside
MD Strategies Research Centers
San Diego
Colorado
Cherry Creek Family Practice
Denver
Florida
Proactive Clinical Research, LLC
Fort Lauderdale
Helios Clinical Research, Inc (former Ventavia Research Group)
Kissimmee
Cordova Research Institute, LLC
Miami
Research Institute of South Florida Inc
Miami
South Florida Research Center, Inc.
Miami
Kendall South Medical Center Inc.
South Miami
Georgia
Agile Clinical Research Trials
Atlanta
Idaho
Clinical Research Prime
Idaho Falls
Indiana
Mishawaka Osteopathic Clinic
Mishawaka
Missouri
Washington University School of Medicine
St Louis
Montana
Mercury Street Medical Group
Butte
Montana Medical Research LLC
Missoula
North Carolina
OnSite Clinical Solutions LLC
Charlotte
Burke Primary Care
Morganton
Nevada
Accent Clinical Trials
Las Vegas
Excel Clinical Research
Las Vegas
Ohio
Hometown Urgent Care and Occupational Health - Springdale
Cincinnati
Pennsylvania
Tristar Clinical Investigations
Philadelphia
Frontier Clinical Research
Scottdale
Frontier Clinical Research
Smithfield
Frontier Clinical Research
Smithfield
South Carolina
Jedda Enterprises dba Galen Clinical Research
Greer
Tennessee
AFC Urgent Care-Gunbarrell
Chattanooga
Helios Clinical Research, Inc (former Ventavia Research Group)
Jackson
Texas
City Doc Urgent Care-Dallas/Ft. Worth
Dallas
Southwest Family Medicine Associates
Dallas
Premier Pulmonary Critical Care and Sleep Medicine
Denison
Fairway Medical Clinic
Houston
Mercury Clinical Research
Houston
Pioneer Research Solutions
Houston
Vilo Research Group
Houston
Family Practice Center
Mcallen
Sun Research Institute
San Antonio
West Virginia
Frontier Clinical Research
Kingwood
Other Locations
Bulgaria
Medical Centre Asklepii, OOD
Dupnitsa
Medical Center Hera Eood
Montana
MHAT Sveta Paraskeva
Pleven
Medizinski Zentrar-1-Sevlievo EOOD
Sevlievo
MHAT Sliven - Military Medial Academy
Sliven
Medical Center Hera Sofia
Sofia
MHAT Sveta Sofia
Sofia
China
Beijing Tsinghua Changgung Hospital
Beijing
Beijing You An Hospital
Beijing
Capital Medical University Beijing Hospital of Traditional Chinese Medicine
Beijing
China-Japan Friendship Hospital
Beijing
West China Hospital, Sichuan University
Chengdu
The Third People's Hospital of Hainan Province
Sansha
Shenzhen children's hospital
Shenzhen
Shenzhen People's Hospital
Shenzhen
Taizhou People's Hospital
Taizhou
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou
General Hospital of Ningxia Medical University
Yinchuan
Henan Provincial People's Hospital
Zhengzhou
Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José
Greece
Laiko General Hospital - Uni of Athens
Athens
Sotiria General Hospital of Athens
Athens
Attikon University General Hospital
Chaïdári
Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest
II. Háziorvosi Körzet
Hosszúhetény
Gyermekháziorvosi rendel?- Dr. Újhelyi János
Nyíregyháza
OEC Clinical Research
Zalaegerszeg
India
JSS Hospital
Mysuru
Israel
Kiryat Motzkin Maccabi Medical Center
Kiryat Motzkin
Maccabi health services - Moked Hashalom
Tel Aviv
Japan
Toda Internal Medicine & Neurology Clinic
Akashi
Medical Corporation Houmankai?Umezu?Clinic
Chikushino-shi
Irie Naika Syounika Iin
Fukuoka
Kimura Siro Clinic
Fukuoka
Shin Komonji Hospital
Fukuoka
Iguchi Clinic
Fukuyama
Mashiba Clinic
Hannō
Fujimaki Ent Clinic
Ichikawa
Hisaki Family Clinic
Ichikawa
Kamoike ENT Allergy Clinic
Kagoshima
Moriyama Otolaryngology
Kagoshima
Clinic Kashiwanoha
Kashiwa
Kamezawa Clinic
Kasugai
Oishi Clinic
Kasuyagun
Kanagawa Himawari Clinic
Kawasaki
Takahashi naika
Kawasaki
Morizono medical clinic
Kitakyushu
Osaki Internal and Respiratory Clinic,
Kitakyushu
Sato ENT Clinic
Kitakyushu
Kiheibashi Otolaryngology
Kodaira
Medical corporation Shirayurikai Swing Nozaki Clinic
Musashino
Yaesu Clinic
Naha
Horikawa Clinic
Nonoichi
Funai Ear Nose Throat Clinic
Ōita
Kitada Clinic
Osaka
Lee's Clinic
Osaka
Sunami Internal medicine Clinic
Osaka
Saga Memorial Hospital
Saga
Segawa Hospital
Saitama
Aiiku Hospital
Sapporo
Uehara Clinic
Sapporo
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
Shinagawa City
Wakasa Clinic
Tokorozawa
Denenchofu Family Clinic
Tokyo
Sato Clinic
Tokyo
Seiwa Clinic
Tokyo
Sekino Hospital
Toshima City
Takeru CLINIC
Toyohashi
Tsuchiura Beryl Clinic
Tsuchiura
Medical corporation Seijinkai Takei Clinic
Tsuru
Gushiken-Cardiology and Internal medicine
Urasoe
Uranishi Clinic
Urasoe
Yotsukaido Tokushukai Medical Center
Yotsukaidō
Mexico
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.
Guadalajara
EME RED
Mérida
Merida | Investigacion Clinica
Mérida
Centro Respiratorio de México
México
Centro de Estudios Clinicos de Queretaro (CECLIQ)
Querétaro City
Poland
KLIMED
Bialystok
Centrum Medyczne Lukamed Joanna Luka
Chojnice
KO-MED Centra Kliniczne Sp. z o.o.
Puławy
CLINHOUSE Sp z o.o.
Zabrze
Puerto Rico
Fundacion de Investigacion de Diego
San Juan
South Africa
Into Research
Groenkloof
Newtown Clinical Research
Johannesburg
Langeberg Clinical Trials
Kraaifontein
Midrand Medical Centre
Midrand
Spain
Centro de Salud Las Aguilas
Madrid
Turkey
Ankara Bilkent City Hospital
Ankara
Ankara University Faculty of Medicine Cebeci Hospital
Ankara
Gazi University Medical Faculty
Ankara
Hacettepe University Medical Faculty
Ankara
Akdeniz University Medical Faculty
Antalya
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
Istanbul
Dokuz Eylul University Medical Faculty
Izmir
Ege University Medical Faculty
Izmir
Kocaeli University Medical Faculty
Kocaeli
Karadeniz Technical Uni School of Medicine
Trabzon
United Kingdom
Preston Hill Surgery
Harrow
Time Frame
Start Date: 2019-10-10
Completion Date: 2024-05-10
Participants
Target number of participants: 4138
Treatments
Experimental: Baloxavir Marboxil
Participants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
Placebo_comparator: Placebo
Participants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov