Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 6,400
- 试验地点
- 9
- 主要终点
- Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death
研究概览
简要总结
The aim of this study is to reduce pulmonary complications in adult patients undergoing abdominal or thoracic surgery in COVID-19 exposed hospital environments. A Trial in Low and Middle Income Countries (LMICs)
详细描述
This trial has an adaptive platform design to identify at the earliest opportunity intervention arms which are showing benefit, drop arms which have a clear lack of benefit, and rapidly introduce new therapeutic options to the platform. This will enable rapid feedback of results to clinicians, allowing the standard of care to be modified as the pandemic progresses. Regular and frequent monitoring of results will be guided by an experienced, independent DMC.
Eligible patients will be randomised at the level of the individual in a 1:1 ratio between:
A. Control (normal practice) B. RESP301 6ml mixture of 150mM sodium nitrate, 50mM mannitol and 100mM citric acid, buffered at pH 5.4, three times per day (at least 4 hours apart), for 7 days or until discharge, whichever occurs first
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients aged 18 years and over. (This criteria MUST be made country-specific)
- •Planned to undergo abdominal or thoracic elective or emergency inpatient surgery requiring general anaesthesia.
- •Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms (to be monitored post-surgery for symptoms)
- •Informed patient consent.
- •Able to operate a vibrating mesh nebuliser, as assessed by the recruiting physician
排除标准
- •Procedures under local anaesthesia
- •Known history of adverse reaction/contraindication to trial drug
- •Pregnancy and/or lactating patients (including patients undergoing caesarean section)
- •History of methaemoglobinaemia
- •Patients receiving any type of prescribed nitric oxide-donating agents (e.g. Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
- •Unable to tolerate use of a nebuliser and/or deemed unlikely to be able to adhere to protocol in view of investigator
研究组 & 干预措施
RESP301
RESP301 is administered quickly (8-10 minutes) via an easy-to-use, vibrating mesh nebuliser. The recommended nebulisers used to administer this intervention are available in all participating countries. The intervention will be administered using a nebuliser according to standard local practice; where permitted for patients to self-administer, a member of the clinical team will ensure that the patient has viewed the intervention administration training video, and will also oversee the patient for the first trial dose to ensure proper administration.
干预措施: RESP301 (Drug)
结局指标
主要结局
Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death
时间窗: From randomisation until discharge from hospital, average less than 30 days
The primary outcome is any one of the following, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death
次要结局
- Duration of hospital stay(30 days post-surgery)
- Pulmonary function(30 days post-surgery)
- Rate of ARDs(From randomisation until discharge from hospital, average less than 30 days)
- Rate of Pneumonia(From randomisation until discharge from hospital, average less than 30 days)
- Death rate(From randomisation until discharge from hospital, average less than 30 days)
- Rate of unexpected ventilation(From operation until 30 days post operation)
- COVID-19 pulmonary complications(30 days post-surgery)