Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
- Conditions
- COVID-19
- Registration Number
- PACTR202004893013257
- Lead Sponsor
- Dr Birgit Whitman
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 6400
•Patients aged 16 years and over in Ghana. (This criteria MUST be made country-specific)
•Planned to undergo any type of elective or emergency inpatient surgery requiring general or regional anaesthesia (such as vulnerable patients undergoing surgery for a fractured neck of femur).
•Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms
•Informed patient consent.
•Procedures under local anaesthesia.
•Symptomatic COVID-19 infection (by confirmed COVID-19 test or a clinical diagnosis); these patients will be eligible for the RECOVERY trial.
•Existing regular preoperative treatment with trial drugs.
•Known history of adverse reaction/contraindication to trial drugs.
•Pregnancy (including caesarean section).
•Actively breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Pneumonia<br>•Acute respiratory distress syndrome (ARDS)<br>•Death<br>
- Secondary Outcome Measures
Name Time Method •Pneumonia, ARDS, and death will be presented and analysed separately as secondary outcomes as well as within the composite primary outcome measure. <br>•Unexpected ventilation (unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation up to 30 days after surgery)<br>•Postoperative diagnosis of proven COVID-19 pulmonary complications (the method of diagnosis will be collected, i.e. infection based on microbiological testing or clinical features)<br>•Overall SARS-CoV-2 infected rate (symptomatic and/or asymptomatic).<br>•Duration of hospital stay (including time spent in intensive care, time ventilated)<br>•Pulmonary function in keeping with the WHO Solidarity Trial outcome scale (will be detailed in Appendix 2)<br>