Overview

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

Status:
Recruiting
Trial end date:
2023-02-23
Target enrollment:
0
Participant gender:
All
Summary
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Baloxavir
Criteria
INCLUSION CRITERIA:

Index Patients (IPs):

- Able to comply with the study protocol per investigator judgment.

- Diagnosed with acute influenza infection by investigator.

- Polymerase chain reaction [PCR] (+) or Rapid Influenza Diagnostic Test [RIDT] (+) for
influenza A/B based on cobas® influenza A/B Assay or other point-of-care / local
laboratory results.

- PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 Assay or other
point-of-care / local laboratory result

- Presence of (a) fever (>=38.0 °C per tympanic or rectal thermometer; >=37.5 °C per
axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough,
sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain,
fatigue).

- The time interval between the onset of fever or influenza symptoms and the pre-dose
examinations is 48 hours or less.

- IP lives in a household where: (1) No HHC is known to have been diagnosed with
influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4
weeks (2) All HHCs are expected to meet the key HHC inclusion criteria (3) >=2 HHCs
are expected to participate in the full study who have not received the influenza
vaccine within 6 months prior to screening.

- Women of childbearing potential: Agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures specified in the protocol

All HHCs (Part 1):

- PCR (-) or RIDT (-) based on cobas® influenza A/B Assay or other local point-of-care /
local laboratory result.

- PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 Assay or other
POC / local laboratory result.

- HHC lives with no HHC who will be present in the home at any time during the study and
who meets any HHC exclusion criteria.

- HHC lives with no HHC who does not meet HHC inclusion criteria 1.

- HHC lives in a household where ≥2 HHCs meet all of the following: Start screening
within 24 hours post IP randomization; Have NOT received the influenza vaccine within
6 months prior to screening; and Fulfill full study HHC inclusion criteria part 2.

Full study HHCs (part 2) intended for full study must meet the following additional
criteria for study entry:

- Agree to participate in the full study.

- Able to comply with the study protocol per investigator judgment

- No influenza symptoms within 7 days prior to screening. Alternatively, mild symptoms
are permissible if determined by the investigator to be due to a pre-existing
condition.

- Temperature <38.0 °C (tympanic).

- Will reside in the index patient's house for at least 7 of the next 9 days and will be
present for scheduled study visits.

- Willing and able to measure and record temperature, or have another household member
perform the task on his or her behalf. Furthermore, a responsible adult will assume
responsibility to oversee or perform this task on behalf of minors.

- In the 6 months prior to screening: a) Has not been diagnosed with influenza by a
healthcare professional b) Has not received BXM, peramivir, laninamivir, oseltamivir,
zanamivir, rimantadine, umifenovir, or amantadine.

- Does not have a moderate or worse active infections OR infections requiring systemic
(e.g., oral or intravenous) or otherwise internally administered (e.g., inhaled,
intrathecal) antibiotic/antiviral/antifungal therapy, (topical therapies for mild
external infections allowed).

EXCLUSION CRITERIA:

IPs:

- IPs with severe influenza virus infection requiring inpatient treatment.

- IPs judged by the investigator to be at high risk for complications of influenza.

- IP is ≥12 years old and unable to swallow tablets (not applicable to IPs 5 to 11 year
olds who will receive oral suspension).

- Women who are breastfeeding or have a positive pregnancy test in the pre-dose
examinations.

- IPs with concurrent (non-influenza) infections requiring systemic antimicrobial and/or
antiviral therapy at the pre-dose examinations.

- IPs who have received baloxavir marboxil, peramivir, laninamivir, oseltamivir,
zanamivir, rimantadine, umifenovir or amantadine, or an investigational drug, within
30 days or 5 drug-elimination half-lives, whichever is longer, prior to screening.

- IPs who have received an investigational monoclonal antibody for a viral disease in
the last year.

- Known hypersensitivity to baloxavir marboxil or the drug product excipients.

- IP previously included in the study

- IP lives with an HHC who, based on available information, meets the HHC exclusion
criteria

HHC:

- Pregnant or within 2 weeks post-partum at screening.

- Immunocompromised.

- Less than 2 years old.

- Who have received an investigational therapy within the 30 days or 5 drug elimination
half-lives, whichever is longer, prior to screening.

- Diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional in the
past 4 weeks.

- HHC who plans to arrive home after 24 hours post IP randomization to Day 9 and is not
willing to be consented as soon as possible upon arrival.

- HHC previously included in the study.