A clinical study to see effect of Baloxavir Marboxil drug to reduce spreading of Influenza to other healthy individuals staying same house.
Scientific Title of Study
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
Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg,
Ghatkopar,
Mumbai
MAHARASHTRA
Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg,
Ghatkopar,
Mumbai
MAHARASHTRA
400 086
India
Argentina Brazil China Costa Rica Greece Hong Kong India Israel Japan Mexico Singapore South Africa Spain Switzerland Turkey United States of America United Kingdom Bulgaria France Hungary New Zealand Poland
Department Of Internal Medicine, Division Of Infectious Diseases, Room No 151, 4th Floor, Plot No 2/3/4/5, Survey No 136, 1,Mindspace Rd, Gachibowli, Hyderabad,Telangana 500032, India Hyderabad TELANGANA
9848045814
drnaveen.reddy@aighospitals.com
Dr Pankaj Bhardwaj
AIIMS Jodhpur
Community Medicine & Family Medicine,
School of Public health,2nd floor, Admin block,
Basni, Phase 2, Jodhpur - 342005,Rajasthan, India
Jodhpur RAJASTHAN
8003996903
pankajbhardwajdr@gmail.com
Dr Anil Kumar Awasthi
Ajanta Research centre Ajanta hospital and IVF centre
Department Of General Medicine, Hall A, Internal Medicine Division, Ground Floor, 765, ABC complex, Kanpur road, Alambagh, Lucknow- 226005, UP, India Lucknow UTTAR PRADESH
9415063607
dr.akawasthi@gmail.com
Dr Sumant Mantri
Apollo Hospital
Apollo Research and Innovations
2nd Floor, 3rd Room, Annexe Building,
154-11, Opp. IIM., Bannerghatta Road,
Bangalore, Karnataka – 560076, India. Bangalore KARNATAKA
9900236821
drsumant2000@yahoo.com
Dr Deepak Jeswani
Criticare Hospital & Research Institute
Department Of Internal Medicine, Room No 1, 4th Floor Dhanshree complex, Near Hotel Hardeo, Sitabuldi, Nagpur - 440010
Nagpur MAHARASHTRA
9823939000
deepakjeswani2@yahoo.co.in
Dr Subramanian Swaminathan
Gleneagles Global Health City
439, Embassy Residency Rd, Cheran Nagar, Perumbakkam, Chennai, India, 600100 Chennai TAMIL NADU
9789841925
drsubramanians@gmail.com
Dr Ashish Goyal
Jehangir Clinical Development Centre Pvt. Ltd.
Department Of General Medicine, Room No 23, Ground Floor,Jehangir Clinical Development Center Pvt., Sassoon Road , Pune – 411001 Pune MAHARASHTRA
9372433824
ashish_critical@yahoo.co.in
Dr Priti L Meshram
JJ Hospital
Pulmonary Medicine Department,
First floor, OPD Building, OPD no. 24, JJ Marg, Byculla, Mumbai, Maharashtra- 400008, India Mumbai (Suburban) MAHARASHTRA
9323198298
drpritimeshram@gmail.com
Dr Piyush Arora
JLN Medical College and Hospital
Department Of Respiratory Medicine, Room No 7, Ground Floor, Kala Bagh, Ajmer, Rajasthan- 305001, India Ajmer RAJASTHAN
9887088122
piyusharora23@gmail.com
Dr JayaRaju BS
JSS Hospital
Department of Pulmonology, Pulmonary Medicine Division, Ground Floor,Mahatma Gandhi Road, Mysore - 570004, Karnataka, India Mysore KARNATAKA
7022239083
drjayarajbs@yahoo.com
Dr Jitendra Anand
Kanoria Hospital & Research Centre
Department Of General Medicine, Room No 7, Ground Floor, Airport-Gandhinagar Highway, Bhat Village, Gandhinagar Dist. , Gujarat-382428, India.
Gandhinagar GUJARAT
9824517101
jkanand09@gmail.com
Dr Muralidhar Varma D
Kasturba Medical College and hospital
Department of Medicine, Division of Infectious Diseases, OPD Block B, 2nd floor, Manipal, Udupi, Karnataka-576104 India Udupi KARNATAKA
9845069639
drmuralidharvarma@yahoo.co.in
Dr Rajkumar Nikalje
Lifepoint Multispecialty Hospital
Department Of Pulmonary Medicine, OPD 1 Room, 1st floor,Sr. No. 145/1 Mumbai Bypass Rd, Near Hotel Sayaji, Wakad, Pimpri-Chinchwad, Pune- 411023, Maharashtra, India Pune MAHARASHTRA
9028560535
nikaljeraj80@gmail.com
Dr Sanjay Kulkarni
M S Ramaiah Medical College and Hospitals; Department of Internal Medicine
M S Ramaiah Medical College and Hospitals; Department of Internal Medicine,1st floor, M.S.Ramaiah Advanced Learning Centre, BENGALURU, KARNATAKA Bangalore KARNATAKA
9740362537
ankitharahul@yahoo.com
Dr Murali Mohan BV
Mazumdar Shaw Medical Center - A Unit of Narayana Health
Department Of Pulmonology, Room No 45, Ground Floor, 258 A, Bommasandra Industrial Area, AnekalTaluk, Bangalore - 560099, Karnataka, India Bangalore KARNATAKA
9844097170
bvmuralimohan@gmail.com
Dr Anand Jaiswal
Medanta –The Medicity Hospital
10th Floor, A - Wing, POCU Unit,
Medanta Institute of Education and Research Department,Sec 38, CH Bhaktawar Singh Road,
Gurugram, Haryana-122001, India Gurgaon HARYANA
9582718931
anand.jaiswal@medanta.org
Dr Asish Mondal
Medical College and Hospital Kolkata
Department Of General Medicine, Division Of Internal Medicine, OPD 306, 2nd Floor, 88 College Street Kolkata-700073, INDIA Kolkata WEST BENGAL
9232467518
drasish84@gmail.com
Dr Himanshu Pophale
MTESS SANJEEVAN HOSPITAL
Department Of General Medicine, OPD 1 Room, Chest Division, Ground Floor, Plot no. 23, off Karve Road
Erandawane, Kashibai Khilare Path, Pune 411004, Maharashtra, India Pune MAHARASHTRA
9503939461
drhpophale@gmail.com
Dr Sandeep Kumar Gupta
MV Hospital and Research Centre
Department Of General Medicine, Room No 1, Ground Floor, 314/30, Mirza Mandi Chowk, Lucknow- 226003, UP, India Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr Atul Gogia
Sir Ganga Ram Hospital
Department of Medicine, Room No 1408, Internal Medicine Division, 4th Floor, Old Rajinder Nagar, New Delhi - 110060, India Central DELHI
98910034500
atulgogia@yahoo.com
Dr Tushar Bhagavatprasad Patel
Sterling Hospital
Department Of Internal Medicine, OPD Wing 1, Basement Floor, Sterling Hospital Road, Memnagar, Ahmedabad 380052, Gujarat, India
Ahmadabad GUJARAT
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 suspension (dosed according to body weight) 2 mg/kg up to 20 kg children and 40 mg for above 20 kg children.
Comparator Agent
placebo
A single dose of Oral tablet matching Baloxavir Marboxil 20mg tablet. Single dose of oral suspension matching with Baloxavir Marboxil 2mg/kg oral suspension
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
ExclusionCriteria
Details
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.
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
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
Target Sample Size
Total Sample Size="1130" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This is a randomized, double-blind, multicenter,
parallel-group, placebo-controlled study designed to evaluate the clinical
efficacy of BXM for the reduction of direct transmission of influenza A/B from
OwH IPs to their HHCs. For this household study, IPs with influenza will be
randomized to receive BXM or placebo, and their HHCs will be repeatedly tested
for influenza virus and assessed for influenza symptoms during the next 9 days.
The total number of new HHC infections (symptomatic and asymptomatic) and total
number of new HHC infections associated with symptoms will be key measures used
to evaluate the “virological transmission†and “symptomatic transmissionâ€
endpoints. Approximately 1,130 IPs with influenza and approximately 2,030
evaluable HHCs will participate in the study. Index Patient: Screening and
Randomization Eligible IPs must be aged from ³ 5 to £
64 years old, have influenza symptom onset within 48 hours, test positive for
influenza A/B, and be OwH (i.e., not at high risk for complications of
influenza). Screening assessments informing IP eligibility include physical
examination, vital signs, height and weight, medical history and concomitant
therapies, urine pregnancy testing, and respiratory sampling for influenza
testing. With regard to the household, IPs should be determined at screening to
live with 1 or more HHCs who have not received an influenza vaccine in the past
6 months (“unvaccinated HHCsâ€), are likely to fulfill all HHC eligibility
criteria, and are expected to participate in the “full study†(i.e.,
participate in all study assessments). IPs who meet the eligibility criteria
will be randomized in a 1:1 ratio to receive a single dose of either BXM or
placebo within 2 hours of randomization. The dose and formulation of BXM is
based on weight and age. Index Patient: Post-Randomization Respiratory samples
and AEs will be collected. IPs who are ³ 12 years old will also
complete questionnaires describing their health status and absence from work or
school. IPs who are < 12 years old will be asked to complete a
questionnaire on the palatability and acceptability of the study drug oral
suspension. Household Contacts: Screening and Enrollment All HHCs present in
the home must have their screening visit start within 24 hours of IP
randomization. If any HHC tests positive for influenza A/B, then all HHCs fail
screening. If 1 or more unvaccinated HHCs meet all HHC eligibility criteria and
agree to participate in the full study, it is allowable for additional HHCs to
not participate beyond the screening visit (even if Baloxavir Marboxil—F.
Hoffmann-La Roche Ltd 18/Protocol MV40618, Version 4 they meet all HHC
eligibility criteria). There is no maximum number of vaccinated and
unvaccinated HHCs that can participate in the full study. HHCs who agree to
participate in the full study (“full study HHCsâ€) must meet the full study
criteria (HHC inclusion criteria 7 to 14), including that they must reside in
the household for 7 of the 9 study days, and must not have any influenza
symptoms at screening (mild symptoms determined by the investigator to be due
to a preexisting condition are allowed). Screening assessments informing HHC
eligibility include influenza symptoms, medical history, concomitant
medications, and respiratory sampling for influenza testing. Full Study
Household Contacts: Post-Screening Only full study HHCs participate in visits
and assessments post-screening. Full study HHCs are monitored for new or
worsening influenza symptoms, and will also maintain a daily temperature diary.
HHCs will be instructed to telephone the site if they develop influenza symptoms
or fever so that a scheduled or unscheduled visit occurring within 24 hours can
be arranged. Respiratory samples, adverse events due to study procedures, and
concomitant medications will be collected. Study Visits The IP screening visit
must occur at the study site. All other visits for IPs and HHCs may be
conducted at home or at the study site. Home visits may be performed by home
nurses or by site staff (if local practices are in place). All assessments
except respiratory swab collection may be conducted remotely (e.g., via
telephone or computer). SARS-CoV-2 Testing Given overlapping influenza and
coronavirus disease 2019 symptoms, severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) testing will be conducted at screening and as needed
during study conduct. If any subject (IP or HHC) tests positive for SARS-CoV-2,
then all subjects in the household should be discontinued.