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A Study to Confirm Efficacy of a Single Dose of Baloxavir Marboxil in the Post-exposure Prophylaxis (PEP) of Influenza Virus Infection in Chinese Participants

ConditionsInfluenza, HumanRespiratory Tract InfectionsPost-exposure Prophylaxis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5+
SponsorHoffmann-La Roche

About this trial

The main purpose of the study is to evaluate the efficacy of a single dose of baloxavir marboxil compared with placebo in the PEP of influenza virus infection with respect to symptomatic, laboratory-confirmed influenza in participants who are household contacts (HHCs) of participants with influenza (index participants).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

First participant in a household with influenza virus infection in the current influenza season

Fewer than 6 HHCs

Agreement by all household members to participate in the study and comply with the study protocol for the duration of the study

Diagnosed as having influenza with positive rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) result

Disqualifiers

Diagnosed with influenza during the current influenza season

Unable to live with the index patient from screening until Day 10

Live with a household member who has any influenza-like symptom(s) other than the index participant on the day of screening

Live with household members other than the index participant who was diagnosed with or strongly suspected to have influenza during the current influenza season

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baloxavir marboxil

    Drug

    Baloxavir marboxil will be administered to the HHCs as per the schedule specified in the protocol.

  • Placebo

    Drug

    Baloxavir marboxil matching placebo will be administered to the HHCs as per the schedule specified in the protocol.

Treatment groups

325 Participants
are divided into 3 treatment groups
Group A: Baloxavir MarboxilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants who are Infected With Influenza Virus (Reverse Transcription - Polymerase Chain Reaction [RT-PCR] Positive), and Present With Fever and at Least one Respiratory Symptom

Time frame
From Day 1 up to Day 10

Secondary outcomes

1

Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive), and Present With Fever or at Least one Influenza Symptom (Respiratory or Systemic)

Time frame
From Day 1 up to Day 10
2

Percentage of Participants who are Infected With Influenza Virus (RT-PCR Positive) Regardless of Body Temperature or Influenza Symptoms

Time frame
From Day 1 up to Day 10
3

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
Up to Day 21

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: