[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617152":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":26,"enrollmentInfo":85,"targetDuration":26,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":105,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute Influenza A\u002FB - Matched placebo for Baloxavir","PLACEBO_COMPARATOR","Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.",[13],"Drug: Placebo Control",{"label":15,"type":16,"description":17,"interventionNames":18},"Acute Influenza A\u002FB - Baloxavir","EXPERIMENTAL","The adaptative platform trial will assess therapeutics for influenza A\u002FB in out-patient setting. Interventions include: Baloxavir. Baloxavir dose: if weight \\\u003C80 kg: one 40 mg dose for 1 day; if weight ≥80kg, one 80 mg dose for one day.",[19],"Drug: Baloxavir",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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\u002FB. This sub-protocol is part of the influenza domain within TreatResp.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Control","Matching placebo for Baloxavir",[9],[32],{"name":33,"affiliation":5,"role":34},"Andrew Pinto, MD","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Upstream Lab Upstream Lab","CONTACT","4168646060","76148","Upstreamlab@unityhealth.to",{"name":43,"role":38,"phone":26,"phoneExt":26,"email":44},"TreatResp Study team","TreatResp@unityhealth.to",[46],{"facility":5,"status":26,"city":47,"state":48,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Toronto","Ontario","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58,62,65],{"name":59,"role":38,"phone":60,"phoneExt":26,"email":61},"Benita Hoseeini, Phd","416-864-6060","Benita.Hosseini@unityhealth.to",{"name":63,"role":38,"phone":26,"phoneExt":26,"email":64},"Kawsika Sivayoganathan, H.BSc","kawsika.sivayoganathan@unityhealth.to",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrew Pinto","Principal Investigator",[70,73],{"name":71,"class":72},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":74,"class":72},"Health Canada","100617152","phase-3-adaptive-platform-trial-of-treatments-for-respiratory-infections-in-community-settings-treatresp-100617152",false,"NCT07314905","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings","TreatResp","Inclusion Criteria:\n\n* 18 years or older\n* A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A\u002FB, or other future specified respiratory pathogens),\n* 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).\n* At least two symptoms commonly associated with respiratory infections, including:\n\n  * rhinitis\n  * cough\n  * wheezing\n  * sore throat\n  * nasal congestion\n  * shortness of breath\n  * fatigue\n  * rapid breathing\n  * excessive mucus production\n  * loss of smell or taste\n  * hemoptysis\n  * trouble sleeping or insomnia due to breathing difficulties\n  * fever (defined for purposes of this study as \\>37.5°C\u002F 41).\n\nExclusion Criteria:\n\n* Admitted to hospital or in an ED for more than 24 hours\n* Previously randomized to TreatResp within the past 12 months\n* Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not\u002Fsuspected not compatible with the study therapeutics\n* Already taking a study therapeutic or contraindication to a study therapeutic\n* Inability for participant or caregiver to provide informed consent.\n\nAdditional 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.\n\nBaloxavir exclusion:\n\n* Has a known or suspected pregnancy\n* Is breastfeeding\n* Is of childbearing potential and is not willing to use a highly effective contraceptive\n* Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \\\u003C60 mL\u002Fmin, and severe renal impairment (eGFR \\\u003C30 ml\u002Fmin, CKD stage 4-5)\n* Has severe hepatic impairment, or requires a live viral vaccine within the next seven days\n* Has a significant impaired immunity (e.g., due to long-term oral steroids, chemotherapy, or an immune disorder)\n* Requires immediate antiviral treatment or hospitalization as per the clinician's judgment\n* Is allergic to trial medications\n* Is scheduled for elective surgery or procedures requiring general anesthesia within the next two weeks\n* Is co-infected with viruses of interest\n* Received a live viral vaccine within the last 14 days","ALL","18 Years",{"count":86,"type":87},264,"ESTIMATED","INTERVENTIONAL",[90],"PHASE3","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.",[93,94,95,96],"Influenza A","Influenza B","SAR-CoV-2","Acute Respiratory Infections (ARIs)",[98,99,93,94,100,101,102,103,104],"COVID-19","SARS-CoV-2","Influenza","Respiratory pathogens","Respiratory infections","Adaptative Platform Trials (APT)","acute respiratory infections (ARIs)","NOT_YET_RECRUITING","2025-12-31",{"date":108,"type":109},"2026-01-02","ACTUAL",{"date":108,"type":87},{"date":112,"type":87},"2027-04-24",{"name":5,"class":6},1]