A Phase 3 interventional study of Baloxavir and Placebo Control in Influenza A, Influenza B and SAR-CoV-2, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Unity Health Toronto · Phase 3, Interventional, and Treatment
Among 13 studies in COVID-19 by Unity Health Toronto — 3 open to participants now, 4 under way, 2 of them phase 3. COVID-19 · Unity Health Toronto.
Among the 13 studies in COVID-19 by Unity Health Toronto, this one is the 6th largest by planned enrollment of the 12 interventional ones, is the only one that started in 2026, is one of 3 in phase 3, and was the 13th registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 264 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →3 of the 13 studies in COVID-19 by Unity Health Toronto are open now, in 8 countries. Each count lists the studies.
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 1 started in 2026.
Median enrollment 222 across the 12 interventional studies, 851 across the 1 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
2 of the studies in COVID-19 by Unity Health Toronto that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07314905Phase 3Unity Health TorontoAdaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) | 2027-03-31 |
| NCT03963622Unity Health TorontoCareful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19) | 2027-06 |
Among the 13 studies in COVID-19 by Unity Health Toronto, from their registry updates:
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. Participants will be randomized to receive usual care (i.e., supportive care and symptom relief) or a study therapeutic, which will be determined by the TreatResp Therapeutics Committee. The primary outcomes being evaluated is time to recovery.
Effective and affordable therapeutics for respiratory pathogens that can be used easily in community settings are needed to accelerate recovery, prevent hospitalizations and deaths. The Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp) will evaluate the clinical effectiveness and cost-effectiveness of therapeutics for respiratory pathogens in non-hospitalized patients. Adaptive platform trials (APTs) are designed to compare multiple therapies in an efficient manner and allow us to respond to the dynamic nature of pandemics. Therapeutics to be evaluated will be identified through a transparent TreatResp Therapeutics Committee. The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered), and key secondary outcomes include all-cause emergency department (ED) visit and/or hospitalization and/or death at 28 days, time to sustained resolution, time to progression of signs or symptoms, symptom severity, quality of life, and cost-effectiveness of each therapeutic. TreatResp leverages our CBRF funded Pandemic Preparedness Engaging Primary Care and Emergency Departments (PREPARED) initiative to recruit participants to the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least two symptoms commonly associated with respiratory infections, including:
Exclusion Criteria:
Additional eligibility criteria will be applied based on the intervention assigned. For instance, if a participant is randomized to an antiviral treatment, they must not have contraindications specific to that antiviral. This ensures that each treatment is evaluated in a population for whom it is most appropriate and safe.
Baloxavir exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.
Drug: Placebo Control
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.
Drug: Baloxavir
This is a sub-protocol within the TreatResp adaptive platform trial to compare the clinical and cost-effectiveness of Baloxavir, a single 40mg or 80 mg tablet based on patient weight, to a matching placebo among non-hospitalized patients with mild to moderate influenza A/B. This sub-protocol is part of the influenza domain within TreatResp.
Matching placebo for Baloxavir
time to recovery (defined as the first instance that a participant report feeling fully recovered)
The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered)
Time frame: Day 1 to Day 28
All-cause emergency department (ED) visits
All-cause emergency department (ED) visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.
Time frame: Day 1 to Day 28
All-cause hospitalization visits
All-cause hospitalization visits from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.
Time frame: Day 1 to Day 28
All-cause death
All-cause death at 28 days from randomization to 28 days, captured during participant daily diaries and corroborated with administrative data where possible, using administrative data holdings.
Time frame: Day 1 to Day 28
Symptom severity obtained through daily diaries questionnaire
Symptom severity obtained through daily diaries questionnaire using the questions: "How is your general health? where 0 is poor and 5 is excellent and by rating symptoms, if present, as "No symptoms, mild, moderate, severe or very severe."
Time frame: Day 1 to Day 28
Quality of life obtained through the daily dairies using EQ-5D-5L
Quality of life obtained through the daily dairies using EQ-5D-5L
Time frame: Day 1 to Day 28
Costs and cost/QALY
Costs and cost/QALY assessed using data from participant daily diaries capturing health care use and treatment, combined with health-related quality of life measures.
Time frame: Day 1 to Day 28
Plan to share: Yes — Our team is dedicated to making data accessible to researchers upon request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: End of study (TBD) and upon request until 15years after study completion.
Access criteria: Study PI
Data sharing details ↗ · upstreamlab.org
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Baloxavir