COVIDSurgRCT_v1.0_20200330
Research type
Research Study
Full title
Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19\n
IRAS ID
282349
Contact name
Aneel Bhangu
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2020-001448-24
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Surgical patients represent a highly vulnerable patient group, who are at particular risk of COVID-19 exposure and complications whilst in hospital for essential surgical treatment. They are vulnerable because of their underlying comorbidity and also because they will be subjected to artificial ventilation at the time of surgery. \n\nThere are currently no interventional trials looking to prevent or mitigate the pulmonary complications associated with concurrent COVID-19 infection acquired either just before surgery or during the post-operative stay in hospital. \n\nThe aim of this study is to reduce COVID-19 related pulmonary complications in adult patients undergoing all types of elective or emergency surgery. Studies are already in set-up testing treatments for advanced COVID-19 infection and prophylaxis in healthy healthcare workers (clinicaltrials.gov: NCT04318444 and NCT04318015). We are not aware of any registered trials testing strategies to reduce the impact of COVID-19 in patients undergoing surgery.\n\nAny hospital performing elective or emergency adult surgery that has recorded at least one case of COVID-19 is eligible. Include surgery types are intentionally broad and include abdominal, head and neck, neurosurgery, cardiothoracic, gynaecology, and trauma & orthopaedic surgery. \n\nParticipants will be recruited from hospitals in a variety of settings across Low & Middle Income Countries (LMICs) and High Income Countries (HICs) and will be randomised to one of a number of treatment options involving oral medications starting just prior to surgery and to be taken until discharge.\n \nThis trial is relevant to all countries and is looking to repurpose drugs that are widely available across many LMICs. It is likely that some interventions, yet to be introduced within the adaptive design, may only be available in specific settings. At a global level, individual countries will be able to recruit to certain arms as is feasible due to regulations and drug availability (accepting this may evolve through the study period within an adaptive trial platform).
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0131
Date of REC Opinion
15 Apr 2020
REC opinion
Further Information Favourable Opinion