Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 2
- 主要终点
- time to recovery (defined as the first instance that a participant report feeling fully recovered)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Research study staff (Research Assistants, PI, Statistician, QI, Co-PI, Manager and Coordinators)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •sore throat
- •nasal congestion
- •shortness of breath
- •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).
排除标准
- •Admitted to hospital or in an ED for more than 24 hours
- •Previously randomized 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 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:
- •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
研究组 & 干预措施
Acute Influenza A/B - Baloxavir
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.
干预措施: Baloxavir (Drug)
Acute Influenza A/B - Matched placebo for Baloxavir
Usual Care (i.e., supportive care and symptom relief). Matching control placebo for Baloxavir - a single matching dose.
干预措施: Placebo Control (Drug)
结局指标
主要结局
time to recovery (defined as the first instance that a participant report feeling fully recovered)
时间窗: Day 1 to Day 28
The primary outcome is time to recovery (defined as the first instance that a participant report feeling fully recovered)
次要结局
- All-cause emergency department (ED) visits(Day 1 to Day 28)
- All-cause hospitalization visits(Day 1 to Day 28)
- Symptom severity obtained through daily diaries questionnaire(Day 1 to Day 28)
- All-cause death(Day 1 to Day 28)
- Costs and cost/QALY(Day 1 to Day 28)
- Quality of life obtained through the daily dairies using EQ-5D-5L(Day 1 to Day 28)
研究者
Andrew Pinto
Principal Investigator
Unity Health Toronto