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 - CENTERSTONE

Roche Products India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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

•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.

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