Health Condition 1: J09X- Influenza due to identified novelinfluenza A virus
Conditions
Interventions
Intervention1: Baloxavir Marboxil: Single oral dose of 20mg tablet (dosed according to body weight) - 40 mg for patients up to 80 kgs and 80mg for patients more then 80kgs
Single oral dose of suspensi
Sponsors
Roche Products India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. PCR (+) or RIDT (+) for influenza A/B based on cobas SARS-CoV-2 & Influenza A/B test or other point-of-care/local laboratory results. 2. No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks. 3. All HHCs are expected to meet the key HHC inclusion criteria (criteria 1, 2, 3, 4, 5, and 6) Has not received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, amantadine, or favipiravir
Exclusion criteria
Exclusion criteria: 1. Chronic respiratory diseases including chronic obstructive pulmonary disease, current asthma, and cystic fibrosis 2. Neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (e.g., cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury); 3. Compromised immune system due to disease (such as people with HIV or AIDS, or some cancers such as leukemia) or medications (such as those receiving chemotherapy or radiation treatment for cancer, or persons with chronic conditions requiring chronic corticosteroids or other drugs that suppress the immune system); 4. People younger than 19 years of age on long-term aspirin- or salicylate-containing medications; m) People from certain racial and ethnic minority groups are at increased risk for hospitalization with influenza, including non-Hispanic Black persons, Hispanic or Latino persons, and American Indian or Alaska Native persons. The investigator should consider the overall risk of the individual.; n) People who live in nursing homes and other long-term care facilities. IP who has received BXM, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, amantadine, or favipiravir within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy objective for this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo to prevent secondary within-household transmission of influenza A/BTimepoint: proportion of household contacts to become PCR positive for influenza by Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy objective for this study is to evaluate the efficacy of a single, oral dose of BXM compared with placebo to prevent virological or symptomatic transmission of influenza A/B & effects beyond secondary within-household transmission according to the measures belowTimepoint: Proportion of HHCs who become PCR (Positive) [confirmed at central laboratory] for influenza by Day 9 Visit, with virus subtype consistent with IP | — |
Countries
Argentina, Brazil, Bulgaria, China, Costa Rica, France, Greece, Hong Kong, Hungary, India, Israel, Japan, Mexico, New Zealand, Poland, Singapore, South Africa, Spain, Switzerland, Turkey, United Kingdom, United States of America
Contacts
Public ContactManjula Ujagiri
Roche Products India Pvt. Ltd.
Outcome results
None listed