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

Phase 3
Completed
Conditions
Influenza
Interventions
Registration Number
NCT03969212
Lead Sponsor
Hoffmann-La Roche
Brief 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 1 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
4138
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboParticipants who are IPs will receive a single oral dose of placebo. HHCs of the IPs will not receive study medication.
Baloxavir MarboxilBaloxavir MarboxilParticipants who are IPs will receive a single oral dose of baloxavir marboxil. HHCs of the IPs will not receive study medication.
Primary Outcome Measures
NameTimeMethod
Percentage of HHCs With Virological Influenza Transmission by Day 5Baseline (Day 1) to Day 5

The virological transmission was determined based on Polymerase Chain Reaction Positive (PCR+) influenza test results. The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of the respective IP, irrespective of being symptomatic or asymptomatic. The adjusted incidence rates presented were estimated using a generalized estimating equations (GEE) approach.

Secondary Outcome Measures
NameTimeMethod
Percentage of HHCs With Symptomatic Influenza Transmission by Day 5Baseline (Day 1) to Day 5

The adjusted incidence (cumulative proportion of events by Day 5) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 5 post IP randomization with virus subtype matching with that of respective IP, \& developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years old were symptomatic if 1. Presence of temperature ≥38.0 Celsius (C) and 1 respiratory symptom (cough, sore throat, nasal congestion) or 2. Presence of 1 respiratory symptom and 1 general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with/without a fever. HHCs ≥2 and \<12 years old were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory tract infection signs or symptoms (cough, nasal congestion, or rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.

Percentage of Households (HHs) With Virological Influenza Transmission at Household Level by Day 5Baseline (Day 1) to Day 5

Percentage of households with at least one HHC who met the primary endpoint of virological transmission by Day 5 are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.

Percentage of HHs With Symptomatic Influenza Transmission at Household Level by Day 5Baseline (Day 1) to Day 5

Percentage of HHs with at least one HHC who meets the symptomatic transmission by Day 5 endpoint are reported here. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.

Percentage of HHCs With Virological Influenza Transmission by Day 9Baseline (Day 1) to Day 9

The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization with virus subtype matching with the respective IP, irrespective of being symptomatic or asymptomatic including: 1. all HHC meeting primary endpoint, AND 2. all HHC cases detected after Day 5 meeting the following criteria: 2a. included HHC case was in an HH where another HHC had already met the primary endpoint OR 2b. included HHC case was PCR+ bearing an amino acid substitution of isoleucine for another amino acid at position 38 (I38X) in the polymerase acidic (PA) protein (PA/I38X substitution) or amino acid substitution of threonine to lysine at position 20 in the PA protein for influenza B only (PA/T20K). The adjusted incidence rates presented were estimated using a GEE approach.

Percentage of HHCs With Symptomatic Influenza Transmission by Day 9Baseline (Day 1) to Day 9

The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological transmission by Day 9 endpoint and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had 1. temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or 2. one respiratory and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (headache, feverishness or chills, muscle or joint pain, fatigue). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.

Percentage of HHCs With Any Virological Infection by Day 9Baseline (Day 1) to Day 9

Virological infection was defined as HHCs who tested PCR+ for influenza by Day 9 post IP randomization based on PCR influenza test results. The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who met the virological infection by Day 9 endpoint. The adjusted incidence rates presented were estimated using a GEE approach.

Percentage of HHs With Any Virological Infection at HH Level by Day 9Baseline (Day 1) to Day 9

Virological infection at the HH level was defined as the HHs with at least one HHC who met the endpoint of any virological infection by Day 9. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.

Percentage of HHCs With Any Symptomatic Infection by Day 9Baseline (Day 1) to Day 9

The adjusted incidence (cumulative proportion of events by Day 9) rate is reported here. This is defined as percentage of HHCs who tested PCR+ for influenza by Day 9 post IP randomization and developed symptoms at any time during the study. The adjusted incidence rates presented were estimated using a GEE approach. HHCs ≥12 years were symptomatic if they had (1) a temperature ≥38.0°C and one respiratory symptom (cough, sore throat, nasal congestion) or (2) one respiratory and one systemic symptom (headache, chills, muscle/joint pain, fatigue), with or without fever. HHCs ≥2 and \<12 years were symptomatic if the presence of temperature was ≥38.0°C and had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be either new or have worsened versus baseline in HHC with baseline symptoms due to a preexisting comorbidity.

Percentage of HHs With Any Symptomatic Infection at HH Level by Day 9Baseline (Day 1) to Day 9

Percentage of HHs with at least one HHC who meets the endpoint of any symptomatic infection by Day 9 are reported here. HHCs ≥12 years were symptomatic if they had 1. a temperature ≥38.0°C \&1 respiratory symptom (cough, sore throat, nasal congestion) or 2. 1 respiratory \& 1 systemic symptom (headache, chills, muscle/joint pain, fatigue), with/without fever. HHCs ≥2 \& \<12 years were symptomatic if the temperature was ≥38.0°C \& had upper respiratory symptoms (cough, nasal congestion, rhinorrhea). Symptoms must be new or have worsened versus baseline in HHC with baseline symptoms due to preexisting comorbidity. 'Number of participants analyzed' is the number of IPs in the PAS-IP set.

Number of IPs With Adverse Events (AEs)Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

Number of IPs With Serious Adverse Events (SAEs)Baseline up to Day 9 (for IPs ≥12 years old) and Day 21 (for IPs <12 years old)

A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Trial Locations

Locations (138)

Cahaba Research, Inc.

🇺🇸

Birmingham, Alabama, United States

Cahaba Research, Inc

🇺🇸

Pelham, Alabama, United States

Precision Trials

🇺🇸

Phoenix, Arizona, United States

Hope Clinical Research

🇺🇸

Canoga Park, California, United States

Long Beach Clinical Trials

🇺🇸

Long Beach, California, United States

Downtown LA Research Center

🇺🇸

Los Angeles, California, United States

Probe Clinical Research

🇺🇸

Riverside, California, United States

MD Strategies Research Centers

🇺🇸

San Diego, California, United States

Cherry Creek Family Practice

🇺🇸

Denver, Colorado, United States

Proactive Clinical Research, LLC

🇺🇸

Fort Lauderdale, Florida, United States

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Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States

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