Open-label, Controlled, Randomized Clinical Trial on the Efficacy of Early Prone-positioning in Patients With Mild Pneumonia Due to SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Accomplishment of the end-points
研究概览
简要总结
The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions.
Patients will be randomized on a 1:1 ratio and stratified based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
One branch of patients (interventional) will undergo standard of care treatment + prone-positioning cycles, the other one (controll) will undergo standard of care treatment alone.
Patients will be evaluated evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first).
Adverse events and concurrent medications will be noted as well.
The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods.
详细描述
In this prospective, unicentred, open, controlled study, patients will be randomized on a 1:1 ratio using casual permutation blocks, identifying two branches of treatment: standard of care; standard of care + prone positioning. Patients will be stratified in 4 strata based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).
In order to obtain statistical significance, the sample size will include 96 patients.
Patients in the SOC + prone-positioning branch will undergo cycles of prone-positioning following this scheme: 3-6 hours of prone-positioning twice a day. The actual length of the cycles will be registered during the study.
Data will be collected using a dedicated CRF, which will include recording of adverse events and concurrent medications.
Patients will be evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first). If dismissal occurs before day 28, a follow-up interview will be conducted in presence or on the phone to collect the remaining data.
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
- •> 18 years
- •positive PCR for Sars-Cov-2 Rna on any respiratory samples within 7 days from enrollment
- •imaging positive for pulmonary involvement or clinical evidence of respiratory involvement ( new onest of hypoxemia with 02 <80mmHg or SpO2 < 94% in air or need for oxygen therapy in oreder to mantaine SpO2 > 93%.
- •need of hospitalization
排除标准
- •start of prone-positioning cycles before being enrolled in the study
- •SpO2/FiO2 <200
- •need of high-flow oxygen therapy (HFNC) or need of non-invasive ventilation and/or CPAP or indications for intubation and mechanical ventilation
- •relative or absolute contraindications for prone positioning (eg facial fractures, advanced pregnancy, mental status alterations, spinal instability...)
研究组 & 干预措施
Standard of care + prone positioning
Standard of care. Prone-positioning cycles as the following: 3-6 hours of prone-positioning twice a day.
干预措施: prone positioning (Procedure)
Standard of care
Standard of care
结局指标
主要结局
Accomplishment of the end-points
时间窗: 0-28 days
the occurence of the first of the following end-points: death, start of high flow oxygen therapy, CPAP, meccanichal ventilation, P/F \<200
次要结局
- number of adverse event(0-28 days)
- time of recovery(0-28 days)
- time of weaning from oxygen(0-28 days)
- variation of the clinical condition(0-28 days)
- mortality(0-28 days)
- number and duration of prone positioning cycles(0-28 days)
研究者
Paolo Bonfanti
Director of Infectious Diseases Department
University of Milano Bicocca