Trial Outcomes & Findings for Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (NCT NCT04141930)

NCT ID: NCT04141930

Last Updated: 2021-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

481 participants

Primary outcome timeframe

Up to 48 hours

Results posted on

2021-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	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. Individuals need to be eligible based on on-label use according to their age and medical history. Baloxavir Marboxil: Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset	Study Drug Ineligible Individuals not eligible to receive on-label use of Baloxavir due to age or medical history
Overall Study STARTED	302	179
Overall Study COMPLETED	302	179
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Drug Eligible n=481 Participants 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
Age, Categorical <=18 years	221 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	250 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	253 Participants n=5 Participants
Sex: Female, Male Male	228 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	439 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	408 Participants n=5 Participants
Race (NIH/OMB) More than one race	31 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants
Region of Enrollment United States	481 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 48 hours

Outcome measures

Outcome measures
Measure	Study Drug Eligible n=8 Participants 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
Initiate Antiviral Therapy Within 48 Hours of Symptom Onset	8 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Study Drug Eligible n=12 Participants 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
Home Influenza Tests Confirmed by Laboratory Testing	8 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Study Drug Eligible n=8 Participants 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
Delivered Antivirals Within 48 Hours of Symptom Onset	8 Participants

Adverse Events

Study Drug Eligible

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Drug Eligible n=302 participants at risk 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
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.33% 1/302 • Number of events 1 • 14 days after receipt of antiviral

Other adverse events

Other adverse events
Measure	Study Drug Eligible n=302 participants at risk 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
Gastrointestinal disorders Diarrhea	0.99% 3/302 • Number of events 3 • 14 days after receipt of antiviral
Infections and infestations Headache	0.66% 2/302 • Number of events 2 • 14 days after receipt of antiviral

Additional Information

Research Coordinator

University of Washington

Phone: 2066165859

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place