A clinical study to see effect of Baloxavir Marboxil drug to reduce spreading of Influenza to other healthy individuals staying same house.

Phase 3

Active, not recruiting

Conditions: Influenza due to identified novelinfluenza A virus,

Registration Number: CTRI/2019/12/022490

Lead Sponsor: Roche Products India Private Limited

Brief Summary: This is a randomized, double-blind, multicenter,parallel-group, placebo-controlled study designed to evaluate the clinicalefficacy of BXM for the reduction of direct transmission of influenza A/B fromOwH IPs to their HHCs. For this household study, IPs with influenza will berandomized to receive BXM or placebo, and their HHCs will be repeatedly testedfor influenza virus and assessed for influenza symptoms during the next 9 days.The total number of new HHC infections (symptomatic and asymptomatic) and totalnumber of new HHC infections associated with symptoms will be key measures usedto evaluate the â€œvirological transmissionâ€ and â€œsymptomatic transmissionâ€endpoints. Approximately 1,130 IPs with influenza and approximately 2,030evaluable HHCs will participate in the study. Index Patient: Screening andRandomization Eligible IPs must be aged from Â³ 5 to Â£64 years old, have influenza symptom onset within 48 hours, test positive forinfluenza A/B, and be OwH (i.e., not at high risk for complications ofinfluenza). Screening assessments informing IP eligibility include physicalexamination, vital signs, height and weight, medical history and concomitanttherapies, urine pregnancy testing, and respiratory sampling for influenzatesting. With regard to the household, IPs should be determined at screening tolive with 1 or more HHCs who have not received an influenza vaccine in the past6 months (â€œunvaccinated HHCsâ€), are likely to fulfill all HHC eligibilitycriteria, and are expected to participate in the â€œfull studyâ€ (i.e.,participate in all study assessments). IPs who meet the eligibility criteriawill be randomized in a 1:1 ratio to receive a single dose of either BXM orplacebo within 2 hours of randomization. The dose and formulation of BXM isbased on weight and age. Index Patient: Post-Randomization Respiratory samplesand AEs will be collected. IPs who are Â³ 12 years old will alsocomplete questionnaires describing their health status and absence from work orschool. IPs who are < 12 years old will be asked to complete aquestionnaire on the palatability and acceptability of the study drug oralsuspension. Household Contacts: Screening and Enrollment All HHCs present inthe home must have their screening visit start within 24 hours of IPrandomization. If any HHC tests positive for influenza A/B, then all HHCs failscreening. If 1 or more unvaccinated HHCs meet all HHC eligibility criteria andagree to participate in the full study, it is allowable for additional HHCs tonot participate beyond the screening visit (even if Baloxavir Marboxilâ€”F.Hoffmann-La Roche Ltd 18/Protocol MV40618, Version 4 they meet all HHCeligibility criteria). There is no maximum number of vaccinated andunvaccinated HHCs that can participate in the full study. HHCs who agree toparticipate in the full study (â€œfull study HHCsâ€) must meet the full studycriteria (HHC inclusion criteria 7 to 14), including that they must reside inthe household for 7 of the 9 study days, and must not have any influenzasymptoms at screening (mild symptoms determined by the investigator to be dueto a preexisting condition are allowed). Screening assessments informing HHCeligibility include influenza symptoms, medical history, concomitantmedications, and respiratory sampling for influenza testing. Full StudyHousehold Contacts: Post-Screening Only full study HHCs participate in visitsand assessments post-screening. Full study HHCs are monitored for new orworsening influenza symptoms, and will also maintain a daily temperature diary.HHCs will be instructed to telephone the site if they develop influenza symptomsor fever so that a scheduled or unscheduled visit occurring within 24 hours canbe arranged. Respiratory samples, adverse events due to study procedures, andconcomitant medications will be collected. Study Visits The IP screening visitmust occur at the study site. All other visits for IPs and HHCs may beconducted at home or at the study site. Home visits may be performed by homenurses or by site staff (if local practices are in place). All assessmentsexcept respiratory swab collection may be conducted remotely (e.g., viatelephone or computer). SARS-CoV-2 Testing Given overlapping influenza andcoronavirus disease 2019 symptoms, severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) testing will be conducted at screening and as neededduring study conduct. If any subject (IP or HHC) tests positive for SARS-CoV-2,then all subjects in the household should be discontinued.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 1130

Inclusion Criteria

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.
No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the past 4 weeks.
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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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/B	proportion of household contacts to become PCR positive for influenza by Day 5

Secondary Outcome Measures

Name	Time	Method
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 below	Proportion of HHCs who become PCR (Positive) [confirmed at central laboratory] for influenza by Day 9 Visit, with virus subtype consistent with IP

Trial Locations

Locations (21): AIG Hospitals
🇮🇳
Hyderabad, TELANGANA, India
AIIMS Jodhpur
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Jodhpur, RAJASTHAN, India
Ajanta Research centre Ajanta hospital and IVF centre
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Lucknow, UTTAR PRADESH, India
Apollo Hospital
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Bangalore, KARNATAKA, India
Criticare Hospital & Research Institute
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Nagpur, MAHARASHTRA, India
Gleneagles Global Health City
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Chennai, TAMIL NADU, India
Jehangir Clinical Development Centre Pvt. Ltd.
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Pune, MAHARASHTRA, India
JJ Hospital
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(Suburban), MAHARASHTRA, India
JLN Medical College and Hospital
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Ajmer, RAJASTHAN, India
JSS Hospital
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Mysore, KARNATAKA, India
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AIG Hospitals
🇮🇳Hyderabad, TELANGANA, India
Dr Naveen Chander Reddy Podduturi
Principal investigator
9848045814
drnaveen.reddy@aighospitals.com