A Phase 4 interventional study of Baloxavir Marboxil in Influenza and Respiratory Viral Infection, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-05.
Sponsored by University of Washington · Phase 4, Interventional, and Treatment
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 481 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant
Drug: Baloxavir Marboxil
Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Also known as: Xofluza
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
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
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
| Milestone | Study Drug Eligible | Study Drug Ineligible |
|---|---|---|
| Started | 302 | 179 |
| Completed | 302 | 179 |
| Not completed | 0 | 0 |
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.
| Participants | Study Drug Eligible |
|---|---|
| Initiate Antiviral Therapy Within 48 Hours of Symptom Onset | 8 |
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
| Participants | Study Drug Eligible |
|---|---|
| Home Influenza Tests Confirmed by Laboratory Testing | 8 |
Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral
| Participants | Study Drug Eligible |
|---|---|
| Delivered Antivirals Within 48 Hours of Symptom Onset | 8 |
Collected over 14 days after receipt of antiviral. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Drug Eligible | 0/302 (0%) | 1/302 (0.3%) | 5/302 (1.7%) |
| Event | Study Drug Eligible |
|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/302 |
| Event | Study Drug Eligible |
|---|---|
| DiarrheaGastrointestinal disorders | 3/302 |
| HeadacheInfections and infestations | 2/302 |
Based on individuals that contributed data during the test-and-treat phase of the protocol.
| Age, Categorical(Participants) | Study Drug Eligible |
|---|---|
| <=18 years | 221 |
| Between 18 and 65 years | 250 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Study Drug Eligible |
|---|---|
| Female | 253 |
| Male | 228 |
| Ethnicity (NIH/OMB)(Participants) | Study Drug Eligible |
|---|---|
| Hispanic or Latino | 35 |
| Not Hispanic or Latino | 439 |
| Unknown or Not Reported | 7 |
| Race (NIH/OMB)(Participants) | Study Drug Eligible |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 9 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 8 |
| White | 408 |
| More than one race | 31 |
| Unknown or Not Reported | 23 |
| Region of Enrollment(participants) | Study Drug Eligible |
|---|---|
| United States | 481 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions. All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Washington