Recruiting PHASE3 Influenza A

Clinical trial for Influenza A

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, given as a pill 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
TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients.
  • 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...
  • At least two symptoms commonly associated with respiratory infections, including:
  • rhinitis

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
  • Inability for participant or caregiver to provide informed consent. Additional eligibility criteria will be applied based on the intervention...
  • Has a known or suspected pregnancy
See the full eligibility criteria
Who can join
  • 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).
  • At least two symptoms commonly associated with respiratory infections, including:
  • 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).
What rules you out
  • 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
  • Inability for participant or caregiver to provide informed consent. Additional eligibility criteria will be applied based on the intervention assigned. For instance, if a participant is assigned by chance to an...
  • 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's taking place

  • Toronto, Ontario, Canada

Compensation & support

This study's listing mentions compensation or reimbursement.

No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

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 - 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?

Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.