Phase 4
Completed N=481
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
Source: ClinicalTrials.gov NCT04141930 ↗Enrolled (actual)
481
Serious AEs
0.3%
Results posted
Aug 2021
Primary outcomePrimary: Initiate Antiviral Therapy Within 48 Hours of Symptom Onset — 8 Participants
◆ Published Evidence
Emerging
1citation · ~1 / year
Remote surveillance and detection of SARS-CoV-2 transmission among household members in King County, Washington.
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.
Linked Publications
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Remote surveillance and detection of SARS-CoV-2 transmission among household members in King County, Washington.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initiate Antiviral Therapy Within 48 Hours of Symptom Onset |
8 | — |
| SECONDARY Home Influenza Tests Confirmed by Laboratory Testing |
8 | — |
| SECONDARY Delivered Antivirals Within 48 Hours of Symptom Onset |
8 | — |
Eligibility Criteria
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)
Exclusion Criteria
- Household Level:
- Previous documentation of an influenza infection prior to or during the annual influenza season in any household member prior to enrollment
- Individual Level:
- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
- Individuals with hypersensitivity to baloxavir
- Individuals that already have a tele-health account
- Any individual that has one or more of the following conditions:
- Pregnant
- Currently lactating
- Immunosuppressed or immunocompromised (by disease or medication)
- Cancer
- Liver disease
- Kidney disease
Data sourced from ClinicalTrials.gov (NCT04141930) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.