Effectiveness of Self-proning and Repositioning in Outpatients With COVID-19: a Randomized Controlled Internal Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Composite of hospitalization and all cause mortality
研究概览
简要总结
The rapid development of safe and effective COVID-19 treatment is a global health priority. Numerous studies evaluating therapies for this disease are currently underway, but the majority of these are in hospitalized patients with severe illness. Consequently, there is an urgent need to identify therapies that prevent mild COVID-19 cases in the community from becoming more severe. "Proning" or lying face down in bed has been shown to improve breathing and oxygen levels in COVID-19 patients, reducing the need for breathing tubes and ventilators and increasing survival. The current study will investigate whether proning and repositioning (lying on one's side or sitting up) can prevent mild cases of COVID-19 from becoming more severe resulting in fewer hospitalizations and death. A randomized controlled trial will be used to reduce the risk of bias when testing this intervention. Unvaccinated or partially vaccinated adult patients with a positive COVID-19 test willing to participate and well enough to be treated outside the hospital will be randomly assigned to one of two groups: a home-proning intervention group with instructions and daily reminders to prone and reposition during the day and at night, and a standard care group. Our goal is to assess whether home-proning/repositioning leads to fewer hospitalizations and death when compared with standard care. We'll also compare recovery time, use of antibiotics and follow up emergency department visits between these two groups. The current pilot study will assess the feasibility of a larger investigation or "main trial", meaning it will be small scale test of methods and procedures to be used on a larger scale.
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
- None
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
- •Age ≥18 years
- •Positive SARS-CoV-2 PCR test
- •Presence of two or more of the following criteria:
- •Age>55 years
- •Fever by history or at presentation
- •Dyspnea/shortness of breath
- •Fatigue necessitating daytime bed rest
- •One or more of the following medical conditions:
- •Hypertension
- •Cardiovascular disease
- •Chronic lung disease
- •Chronic kidney disease
- •Obesity (BMI≥30kg/m2)
- •Tachycardia > 110 bpm
- •Oxygen saturation <94%
- •One or more of the following laboratory abnormalities:
- •Lymphocytes <1500/microL
- •ESR > 100 mm/h
- •CRP > 10 mg/L
- •D-Dimer > 1000 ng/mL
- •LDH > 240 U/L
- •Bilateral infiltrates or ground glass opacities on chest x-ray or CT scan
- •Socially and medically fit for discharge
- •Access to a smartphone
排除标准
- •Pregnancy >20/40 weeks
- •Body mass index (BMI) >40 kg/m
- •Skeletal deformities that interfere with proning
- •Developmental delay or cognitive impairment that would preclude patient cooperation
- •Other contraindications to proning including any of the following: recent abdominal surgery, active vomiting, acute intoxication.
- •Unlikely to adhere to the proning protocol according to the treating physician's judgment
- •Fully vaccinated for COVID-19
结局指标
主要结局
Composite of hospitalization and all cause mortality
时间窗: Up to 28 days post-randomization
The primary outcome is a composite of hospital admission and all-cause mortality. This will be ascertained using telephone follow up and deterministic record linkage performed by the Institute for Clinical Evaluative Sciences (ICES) using their Discharge Abstract Database (DAD).
次要结局
- All cause mortality(Up to 28 days post-randomization)
- Follow up emergency department assessment without hospital admission(Up to 28 days post-randomization)
- Hospitalization(Up to 28 days post-randomization)
- Time to functional recovery in days(Up to 28 days post-randomization)
- Use of antibiotics for respiratory illness(Up to 28 days post-randomization)