Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission o… (NCT03969212) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
United States4,138 participantsStarted 2019-10-10
Plain-language 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.
Who can participate
Age range5 Years – 64 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
Index Patients (IPs):
* Able to comply with the study protocol per investigator judgment.
* Diagnosed with acute influenza infection by investigator.
* Polymerase chain reaction \[PCR\] (+) or Rapid Influenza Diagnostic Test \[RIDT\] (+) for influenza A/B based on cobas® SARS-CoV-2 and influenza A/B or other point-of-care / local laboratory results.
* PCR (-) or antigen test (-) for SARS-CoV-2 based on cobas® SARS-CoV-2 and Influenza A/B test or other point-of-care / local laboratory result
* Presence of (a) fever (\>=38.0 °C per tympanic or rectal thermometer; \>=37.5 °C per axillary, oral or forehead/temporal thermometer) or (b) any influenza symptoms (cough, sore throat, nasal congestion, headache, feverishness or chills, muscle or joint pain, fatigue).
* The time interval between the onset of fever or influenza symptoms and the pre-dose examinations is 48 hours or less.
* IP lives in a household where: (1) No HHC is known to have been diagnosed with influenza or SARS-CoV-2 infection by a healthcare professional (HCP) in the past 4 weeks; (2) All HHCs are expected to meet the key HHC inclusion criteria; (3) \>=1 HHCs are expected to participate in the full study who have not received the influenza vaccine within 6 months prior to screening.
* Women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures specified in the protocol
All HHCs (Part 1):
* PCR (-) or RIDT (-) based on c…
What they're measuring
1
Percentage of HHCs With Virological Influenza Transmission by Day 5