Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19

University of Birmingham6,400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

6,400

Conditions

Pulmonary Complications in Surgical Patients COVID Severe Acute Respiratory Syndrome

Interventions

RESP301DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

University Of Abuja Teaching Hospital (Spoke)

Gwagwalada, Nigeria

Lagos University Teaching Hospital (Hub)

Lagos, Nigeria

Nnamdi Azikiwe University Teaching Hospital (Spoke)

Nnewi, Nigeria

University Teaching Hospital of Butare (CHUB) (Spoke)

Outcomes

Primary Outcomes

Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death

The primary outcome is any one of the following, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death

Time frame: From randomisation until discharge from hospital, average less than 30 days

Secondary Outcomes

Rate of Pneumonia

Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.

Time frame: From randomisation until discharge from hospital, average less than 30 days

Rate of ARDs

ARDs will be presented and analysed separately as a secondary outcome measure

Time frame: From randomisation until discharge from hospital, average less than 30 days

Death rate

Death will be presented and analysed separately as a secondary outcome measure

Time frame: From randomisation until discharge from hospital, average less than 30 days

Rate of unexpected ventilation

Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery

Time frame: From operation until 30 days post operation

COVID-19 pulmonary complications

Postoperative diagnosis of proven COVID-19 pulmonary complications

Time frame: 30 days post-surgery

Duration of hospital stay

Duration of hospital stay (including time spent in intensive care, time ventilated)

Data from ClinicalTrials.gov

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