MV40618 - CENTERSTONE - Baloxavir marboxil in influenza transmission
Research type
Research Study
Full title
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
IRAS ID
268625
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2018-004056-37
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
PRIM 41480, LCRN Number
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Influenza virus infection (flu) is an acute respiratory infectious disease caused by the influenza viruses (A, B, C or D), and is spread mainly by droplet infection. The incubation period is 1–4 days, with symptoms such as sudden onset fever, chills, headache, myalgia (muscle pain), cough, sore throat and nasal congestion.
Influenza A and B infections are seasonal and highly contagious. Most individuals are advised to stay at home until their fever has subsided for at least 24 hours, which puts other household members at risk of infection. There are currently no approved treatments proven to reduce influenza transmission.
Baloxavir marboxil (trade name Xofluza®) is a first-in-class influenza antiviral drug approved in the USA, Hong Kong and Japan, for use in individuals aged ≥12 years. It is administered orally as a tablet, in a unique one-dose, one-time regimen. The Phase III CAPSTONE-1 study demonstrated that a single 40 mg/80 mg dose of baloxavir marboxil on Day 1 was well-tolerated, and reduced viral load and symptoms in patients with influenza A or B.
Study MV40618 (CENTERSTONE) (sponsored by Roche) will investigate whether the ability of baloxavir marboxil to reduce viral load, could translate into a reduction in transmission of influenza virus. Potential participants (age 12-64 years) study will present to their GP as standard of care, and if diagnosed with influenza A or B, will be randomised to receive either baloxavir marboxil or placebo (Day 0).
As this is a household study intended to reflect a real-world population, at least 2 eligible household contacts (age ≥2 years) per index patient, will also be enrolled. Household contacts will not receive study treatment. All participants will be monitored until Day 9, using nasopharyngeal (respiratory) swabs and symptoms assessments.The study will last around 1 year. Approximately 1,130 Index Patients and 2,030 household contacts will be enrolled globally.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0248
Date of REC Opinion
11 Sep 2019
REC opinion
Further Information Favourable Opinion