Influenza A study: Baloxavir
Official title Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)
ClinicalTrials.gov ID: NCT07314905
What this study is testing
What is Baloxavir?
Baloxavir is an investigational medicine, taken by mouth, being studied as a potential treatment for influenza a.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn whether the tested medicines help patients recover faster and are cost‑effective compared to usual care.
- Who it's for
- Adults with influenza A, influenza B, COVID‑19 or another acute respiratory infection who are being treated at home.
- What's involved
- You will be randomly assigned, without knowing which you get, to either the study medicine or a placebo, in addition to standard symptom relief, and will have scheduled visits and simple tests to track recovery.
- Time commitment
- You will stay in the study until you recover, with regular clinic or phone visits as directed by the study team.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years or older
- A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A/B, or other future specified respiratory...
- Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or specific interventions within each domain (for...
- rhinitis
- cough
You likely can't join if
- Admitted to hospital or in an ED for more than 24 hours
- Previously assigned by chance to TreatResp within the past 12 months
- Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not/suspected not compatible with...
- Already taking a study therapeutic or contraindication to a study therapeutic
- Has a known or suspected pregnancy
- Is breastfeeding
See the full eligibility criteria
- 18 years or older
- A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A/B, or other future specified respiratory pathogens),
- Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or specific interventions within each domain (for example 72 hours for Baloxavir).
- rhinitis
- cough
- wheezing
- sore throat
- nasal congestion
- shortness of breath
- fatigue
- rapid breathing
- excessive mucus production
- loss of smell or taste
- hemoptysis
- trouble sleeping or insomnia due to breathing difficulties
- fever (defined for purposes of this study as \>37.5°C/ 41).
- Admitted to hospital or in an ED for more than 24 hours
- Previously assigned by chance to TreatResp within the past 12 months
- Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not/suspected not compatible with the study therapeutics
- Already taking a study therapeutic or contraindication to a study therapeutic
- Has a known or suspected pregnancy
- Is breastfeeding
- Is of childbearing potential and is not willing to use a highly effective contraceptive
- Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \<60 mL/min, and severe renal impairment (eGFR \<30 ml/min, CKD stage 4-5)
- Has severe hepatic impairment, or requires a live viral vaccine within the next seven days
- Has a significant impaired immunity (e.g., due to long-term oral steroids, chemotherapy, or an immune disorder)
- Requires immediate antiviral treatment or hospitalization as per the clinician's judgment
- Is allergic to trial medications
- Is scheduled for elective surgery or procedures requiring general anesthesia within the next two weeks
- Is co-infected with viruses of interest
- Received a live viral vaccine within the last 14 days
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.