Influenza, Respiratory Viral Infection
Conditions
Keywords
influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test
Brief summary
This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.
Detailed description
Households represent an important location for transmission of influenza. Rapid delivery of Xofluza may reduce household exposures to influenza among susceptible individuals.This study is a pilot study of a home-based approach to influenza infection control, utilizing self-test kits and rapid home delivery of an antiviral. Households with at least 3 individuals residing there at least 4 days a week, including at least 2 household members that are eligible to take antiviral, will be monitored throughout the influenza season for the onset of a cough or two or more acute respiratory infection symptoms. This study will be conducted in households in the Seattle, WA area for one influenza season, beginning November 1, 2019 and ending April 1, 2020. Household will self-monitor for onset of symptoms throughout the influenza season. When symptoms develop, the participant will self-test for influenza infection using a prepositioned home-testing kit. If negative, the ill participant will provide one self-collected nasal swab specimen. If positive, the ill participant will connect with a healthcare provider via the tele-health app on their smartphone to confirm the influenza diagnosis. Next, if eligible to receive Xofluza, the influenza-positive individual will receive a rapid home delivery of Xofluza within 2-6 hours of the positive test result. All influenza-positive participants will provide a self-collected nasal swab specimen at Study Day 0, Study Day 2-3, and Study Day 5-7. For all illness episodes, the ill individual will complete a questionnaire regarding symptom duration and severity, as well as behavioral changes due to illness.
Interventions
Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Sponsors
Genentech, Inc.
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Household Level: * Group of at least 3 individuals of any ages defined as at least 3 persons residing at the same address for at least 4 days per calendar week * Household group utilizes common household areas * At least 2 household members meeting all individual inclusion/
Exclusion criteria
listed below and willing to participate (e.g. at least two members of the household are 12 years of age or older) * At least one member of the household has a smartphone * Individual Level: Drug Eligible * Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week * Age 12 years or older weighing at least 40 kg (greater than 88 pounds) * Willing and able to take study medication * Willing to comply with all study procedures * English-speaking * Able to provide written, informed consent and/or assent (if applicable) * Permanent mailing address that is available for study staff to mail necessary materials * Individual Level: Drug Ineligible * Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week * Willing to comply with all study procedures * English-speaking * Able to provide written, informed consent and/or assent (if applicable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiate Antiviral Therapy Within 48 Hours of Symptom Onset | Up to 48 hours | Among symptomatic participants, this outcome measure will be calculated by determining the number of home influenza test-positive, drug eligible participants that were prescribed and rapidly delivered baloxavir by the study within 48 hours of symptom onset. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Home Influenza Tests Confirmed by Laboratory Testing | Up to 48 hours | Proportion of individuals who test positive for influenza using the home-based influenza test compared to the number of individuals that test positive for influenza via a PCR laboratory test |
| Delivered Antivirals Within 48 Hours of Symptom Onset | Up to 48 hours | Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Drug Eligible Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant
Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset | 481 |
| Total | 481 |
Baseline characteristics
| Characteristic | Study Drug Eligible |
|---|---|
| Age, Categorical <=18 years | 221 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 250 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 439 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race (NIH/OMB) White | 408 Participants |
| Region of Enrollment United States | 481 participants |
| Sex: Female, Male Female | 253 Participants |
| Sex: Female, Male Male | 228 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 302 |
| other Total, other adverse events | 5 / 302 |
| serious Total, serious adverse events | 1 / 302 |
Outcome results
Primary
Initiate Antiviral Therapy Within 48 Hours of Symptom Onset
Among symptomatic participants, this outcome measure will be calculated by determining the number of home influenza test-positive, drug eligible participants that were prescribed and rapidly delivered baloxavir by the study within 48 hours of symptom onset.
Time frame: Up to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Drug Eligible | Initiate Antiviral Therapy Within 48 Hours of Symptom Onset | 8 Participants |
Secondary
Delivered Antivirals Within 48 Hours of Symptom Onset
Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral
Time frame: Up to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Drug Eligible | Delivered Antivirals Within 48 Hours of Symptom Onset | 8 Participants |
Secondary
Home Influenza Tests Confirmed by Laboratory Testing
Proportion of individuals who test positive for influenza using the home-based influenza test compared to the number of individuals that test positive for influenza via a PCR laboratory test
Time frame: Up to 48 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Drug Eligible | Home Influenza Tests Confirmed by Laboratory Testing | 8 Participants |