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)
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
Drug: RESP301
RESP301 is a formulation consisting of three agents already used in clinical practice: mannitol, sodium nitrite and citric acid. Delivered by a vibrating mesh nebuliser three times per day (TID) (at least 4 hours apart), for 7 days. Each dose of RESP301 is a 6ml admixture of 150mM NaNO2, 50mM mannitol and 100mM citric acid, buffered at pH 5.4.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Donna Smith
+44 (0)121 415 9103
PROTECT-Surg@trials.bham.ac.uk
Rachel Lillywhite
+44 (0)121 414 4762
PROTECT-Surg@trials.bham.ac.uk
Aneel Bhangu, Principal Investigator
University of Birmingham