Baloxavir for Flu
(TreatResp Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new flu treatment called Baloxavir. The goal is to compare Baloxavir's effectiveness to regular flu care, such as rest and symptom relief, in people with the flu. Researchers aim to determine if Baloxavir speeds up recovery. Participants must have tested positive for the flu within the past few days and experience at least two common flu symptoms, such as a cough, fever, or fatigue. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking flu treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop your current medications. However, if you are already taking a study therapeutic or participating in another trial with incompatible treatments, you may not be eligible. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that Baloxavir is likely to be safe for humans?
Research has shown that baloxavir is generally safe for treating the flu in people aged 12 and older. Common side effects include diarrhea, bronchitis, and nausea. However, these side effects occur less frequently with baloxavir than with oseltamivir, another flu treatment. Studies found that the rate of unwanted effects with a single dose of baloxavir is similar to that of a placebo, a harmless pill used for comparison. Although specific data for individuals with very weak immune systems is lacking, the FDA has approved baloxavir for flu treatment, suggesting it is well-tolerated in the general population.12345
Why do researchers think this study treatment might be promising?
Baloxavir is unique because it offers a single-dose treatment option for the flu, which is different from the usual antiviral medications like oseltamivir, which often require multiple doses over several days. Most flu treatments work by inhibiting the neuraminidase enzyme, but Baloxavir targets a different part of the virus's life cycle, blocking the polymerase acidic protein, which is essential for viral replication. This novel mechanism can potentially reduce the duration and severity of flu symptoms more quickly and effectively. Researchers are excited about Baloxavir because its unique approach could lead to faster recovery times and help in managing flu outbreaks more efficiently.
What evidence suggests that Baloxavir might be an effective treatment for flu?
Research has shown that baloxavir, which participants in this trial may receive, effectively reduces the spread of the flu to close contacts after just one dose. It also lowers the likelihood of needing hospital visits compared to other flu treatments like oseltamivir. Specifically, studies found that individuals taking baloxavir had fewer emergency room visits and were less likely to be hospitalized within 1, 3, and 6 months after treatment. This makes baloxavir a promising option for treating the flu outside of the hospital.678910
Who Is on the Research Team?
Andrew Pinto, MD
Principal Investigator
Unity Health Toronto
Are You a Good Fit for This Trial?
This trial is for adults over 18 with symptoms like wheezing, nasal congestion, cough, or sore throat and a positive test for flu or other respiratory pathogens. They must join within 5 days of symptom onset (or sooner for certain treatments).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either usual care or a study therapeutic, such as Baloxavir, for respiratory infections
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured up to 28 days
Long-term follow-up
Participants' health outcomes such as emergency department visits, hospitalizations, and quality of life are tracked
What Are the Treatments Tested in This Trial?
Interventions
- Baloxavir
Trial Overview
TreatResp is testing the effectiveness of Baloxavir compared to placebo in non-hospitalized patients with respiratory infections. It's a double-blind study where participants are randomly chosen to receive either the medication or placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The adaptative platform trial will assess therapeutics for influenza A/B in out-patient setting. Interventions include: Baloxavir. Baloxavir dose: if weight \<80 kg: one 40 mg dose for 1 day; if weight ≥80kg, one 80 mg dose for one day.
Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Health Canada
Collaborator
Citations
1.
news-medical.net
news-medical.net/news/20251217/Baloxavir-reduces-flu-related-hospitalizations-more-than-oseltamivir.aspxBaloxavir reduces flu-related hospitalizations more than ...
According to the findings, baloxavir was associated with greater reductions in rates of hospitalization compared to oseltamivir among influenza ...
Efficacy of Baloxavir Treatment in Preventing Transmission ...
Treatment with a single oral dose of baloxavir led to a lower incidence of transmission of influenza virus to close contacts than placebo.
3.
cidrap.umn.edu
cidrap.umn.edu/influenza-general/study-links-baloxavir-lower-hospitalization-risk-flu-outpatientsStudy links baloxavir to lower hospitalization risk in flu ...
A more granular analysis of the data showed that baloxavir significantly reduced ED visits and hospitalizations among females and patients ...
Comparison of clinical outcomes of oseltamivir versus ...
Baloxavir users had reduced 1-, 3-, and 6-month hospitalization risks. •. ED visits were significantly less frequent with baloxavir treatment. •.
5.
emjreviews.com
emjreviews.com/microbiology-infectious-diseases/news/baloxavir-outperforms-oseltamivir-in-reducing-flu-hospitalisations/Baloxavir Beats Oseltamivir in Reducing Flu Hospitalisations
Results demonstrated that baloxavir users experienced significantly lower rates of hospitalisation at 1, 3, and 6 months post-treatment (0.6%, ...
Important Safety Information for XOFLUZA® (baloxavir ...
The most common side effects of XOFLUZA for treatment of the flu in adults and adolescents (12 years of age and older) were diarrhea, bronchitis, nausea, ...
Safety evaluation of baloxavir marboxil
Data analysis indicates a lower occurrence of adverse reactions with baloxavir marboxil compared to the oseltamivir group. The most frequently ...
Safety profile for flu treatment and post-exposure prophylaxis
Single-dose XOFLUZA had a similar adverse event (AE) rate as placebo—including in patients aged ≥12 years at high risk of developing complications from the flu ...
Influenza Antiviral Medications: Summary for Clinicians
There are no available efficacy, safety, or resistance data for baloxavir monotherapy of influenza in severely immunosuppressed patients and ...
Real-world effectiveness and safety of Baloxavir Marboxil ...
However, according to our best knowledge, there is currently no efficacy and safety data of Baloxavir yet among Chinese influenza patients.
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