TreatResp trial now enrolling participants

The study is open to adults aged 18+ in Ontario who tested positive for a respiratory infection, such as Influenza A or B, with at least two symptoms starting in the last three to five days.

TreatResp is publicly funded research studying medications to see if they can help people with respiratory infections feel better faster and stay out of the hospital.

Who is eligible to participate in the study and how will patients be recruited?

The TreatResp trial relies on volunteers, often referred to as participants, to help us better understand the effectiveness of medications for respiratory infections.

The study is open to

  • Adults aged 18+ in Ontario
  • Who tested positive for a respiratory infection, such as Influenza A or B
  • With at least two symptoms starting within the last three to five days

Symptoms of respiratory infection may include:

  • runny nose
  • cough
  • wheezing
  • sore throat
  • nasal congestion
  • shortness of breath
  • fatigue
  • rapid breathing
  • excessive mucus production
  • loss of smell or taste
  • coughing up blood
  • trouble sleeping or insomnia due to breathing difficulties
  • fever >37.5°C

Click here to complete the pre-screening form

We will recruit patients through referrals from PREPARED, our national research project to help Canada prepare for a future pandemic or public health emergency. TreatResp builds off lessons learned from our previous Canadian trial, CanTreatCOVID, and expands it from COVID to multiple respiratory illnesses. TreatResp, CanTreatCOVID and PREPARED are led by Dr. Andrew Pinto, director of the Upstream Lab at St. Michael’s Hospital, Unity Health Toronto.

Usually, clinical research trials studying medications only involve very few treatments. As researchers are continuously working on innovating existing medications and developing new ones for respiratory pathogens, TreatResp needed to use a study design that would let us study multiple medications over time. Adaptive platform trials (APTs) allow research teams to get approval for a ‘master’ protocol, outlining in detail study procedures and methods, but then add new medications to the trial as they emerge without having to start from the beginning.

An advisory committee will be brought together specifically to review treatments that could be studied. The name of this committee will be the Canadian TreatResp Out-Patient Therapeutics Committee.

We will measure the drug efficacy in several ways. Firstly, we will compare the length of time that symptoms are experienced to see if there is a difference between those who take a study treatment and those who do not (the placebo group). Similarly, we will compare hospitalization rates and death rates at 28 days between the groups. We will also assess changes in quality of life and the usage of health resources to evaluate the cost-effectiveness of each medication and/or combination of medications.

Findings will be shared through publications, media channels, newsletters, social media, and to policymakers and healthcare providers across Canada.

To ensure the findings are shared widely and effectively, the TreatResp team will also work closely with Adaptive platform trials (APTs) internationally.

Participants who are enrolled in the trial will be randomized to receive either a study drug or a placebo. This assignment process is a computerized random process. In addition, both the study drug and the placebo will appear to be similar to study participants, and there will be no outward markings or other ways to tell if the capsule you are taking is study drug or placebo. A placebo medication is used in this study to reduce any potential biases. By reducing bias, we are designing the study in such a way that helps us truly answer the research question. Even though a specific group of individuals will take a placebo treatment instead of the study drug, we know that individuals who have flu symptoms would benefit from more common wellness advice, so we will provide written information that helps all our participants, regardless of the group, to feel better while recovering.

The results of this study will help Canada and other countries in deciding which treatments are most effective in reducing symptom duration, hospitalization and death among patients with respiratory pathogens such as Influenza, while also being cost-effective. Our findings will directly influence standards of care for Influenza infection in community settings in Canada and around the world.

This study will also build experience within Canada with conducting Adaptive Platform Trials (APTs), something that is currently lacking. Beyond Influenza, our APT infrastructure can be adapted to study therapeutics for other upper respiratory pathogens and other diseases in the future.

Frequently Asked Questions

Participants

Participants will

  • Take an Influenza medication approved by Health Canada or a placebo medication
  • Follow public health advice on self-managing Influenza symptoms while recovering
  • Complete a baseline and demographic questionnaire
  • Complete an online diary for 28 days
  • Participants will receive $60 at the conclusion of the 28 day daily diary

There are no costs associated with participating in the study. If participants are randomized to the treatment arm, they will receive the study drug for free.

Participants will receive $60 at the conclusion of the 28 day daily diary.

Referral

  • Anyone can refer adults with a positive Influenza who are 18+, within 3-5 days of symptom onset and with at least two acute respiratory infection symptoms
  • Participants may also contact the study team directly

To refer participants, ask them to

For primary care providers:

  1. This will help you save time. You can refer adults who tested positive for Influenza to our study, and we will screen if they are eligible to receive Influenza medications.
  2. This study is the fastest way to answer whether these medications are effective, particularly in a highly vaccinated population.
  3. This is by primary care providers, for primary care providers! TreatResp is helping us launch the new Canadian Primary Care Trials Network, finally creating evidence in the real world of primary care.

Trial Screening Assessment

We will conduct a risk assessment to verify that individuals meet the study eligibility criteria and are able to receive the study drug. This process will consist of three steps:

Step One: Research Assistant Screening

The research assistant will go through a series of questions with potential participants to determine if they meet the inclusion and exclusion criteria for the study. These questions include demographic information, current health status, and any previous medical conditions or treatments.

Step Two: Medication Review by qualified Study Team Member

If participants are potentially eligible, they will then be connected with a qualified study team member who will review their current medication list to ensure that they are not taking any prohibited drugs. This will help to ensure that any potential interactions or contraindications with the study medication are identified before the participant is enrolled. The qualified study team member could be a pharmacist, physician or nurse practitioner.

Step Three: Final Eligibility Review by Study Physician

As the final step, the study physician will review the participant’s medical history and medication history to confirm their eligibility. The physician will also ensure that the participant meets the inclusion and exclusion criteria and that they have provided informed consent to participate in the study. If a physician conducts Step Two as noted here, that physicians will also conduct Step Three at the same time.

This process helps to ensure that only eligible and suitable participants are enrolled in the study and that the results of the study are accurate and reliable. It also helps to protect the safety and well-being of the participants.

After Enrollment of Participants

  • If participants are randomized to the treatment arm, we will ship the study drug to the participants for free
  • Shipment of the study drug takes approximately 24 hours

  • Participants will be closely monitored by a healthcare team, which helps to ensure that any side effects or complications are identified and addressed quickly
  • Participation in this study provides patients with personalized care and attention, as well as access to specialized resources and support. Dedicated qualified health care professionals are part of the team, and will work with your own primary care (or specialty) providers if there is any doubt about your safety during the study

Participants may decide to complete the study treatment course. 

Depending on the specific circumstances, based on recommendations from the study pharmacist or nurse practitioner, the study physician may decide to end treatment for certain participants, but participants may still be asked to continue completing daily diaries.

No, TreatResp is a double blind, individually randomized multi-centre adaptive platform trial. Participants will be blinded and will receive either the active drug or a placebo medication.

Significance of the Study

  1. Establish an adaptive platform trial aimed at evaluating comparative clinical effectiveness and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens for non-hospitalized patients
  2. Generate evidence relevant to communities made vulnerable by social and economic policies, particularly those historically excluded from research
  3. Provide rapid evidence to inform clinical and health system management and public health leaders, decision-makers, and planners internationally

Patients may choose to participate in a study for several reasons:

  1. TreatResp may be studying treatments that are not already available at your pharmacy. Some treatments may be novel.
  2. Close monitoring: In this study, patients will be closely monitored by a healthcare team, which helps to ensure that any side effects or complications are identified and addressed quickly.
  3. Personalized care: Participation in this study provides patients with personalized care and attention, as well as access to specialized resources and support.
  4. No cost: We cover the cost of treatment and related expenses, so patients do not have to pay for their care.
  5. Contribution to medical research: By participating in this study, patients are contributing to the identification of the most effective therapeutics for non-hospitalized Influenza patients, advancing our understanding of the diseases and improving treatment options for future patients.

It’s important to consider that participating in this study is voluntary and that patients can always decide not to participate or to withdraw from the study at any time.

Our partners

Together we can treat respiratory infections.

Together we can treat respiratory infections.

The TreatResp study is based at Upstream Lab, Unity Health Toronto, and supported by the Canadian Institutes of Health Research (CIHR), Health Canada, and our educational, clinical and research partners.