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

COVID Clinical Trial

— PROTECT-Surg  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04386070
• Other study ID #: RG_20-029 COVID-19
• Secondary ID: 2020-001448-24
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: May 14, 2026

Study information

• Verified date: August 2021
• Source: University of Birmingham
• Contact: Donna Smith
• Phone: +44 (0)121 415 9103
• Email: PROTECT-Surg[@]trials.bham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6400
• Est. completion date: May 14, 2026
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Pulmonary Complications in Surgical Patients
• Severe Acute Respiratory Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
University of Birmingham	Christian Medical College and Hospital, Ludhiana, India, Hospital Español Veracruz, Istituto Clinico Humanitas, Kigali University Teaching Hospital, Tamale Teaching Hospital, Ghana., Université d'Abomey-Calavi, University of Cape Town, University of Edinburgh, University of Lagos, Nigeria, University of Witwatersrand, South Africa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From randomisation until discharge from hospital, average less than 30 days
Secondary	Rate of Pneumonia	Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.	From randomisation until discharge from hospital, average less than 30 days
Secondary	Rate of ARDs	ARDs will be presented and analysed separately as a secondary outcome measure	From randomisation until discharge from hospital, average less than 30 days
Secondary	Death rate	Death will be presented and analysed separately as a secondary outcome measure	From randomisation until discharge from hospital, average less than 30 days
Secondary	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	From operation until 30 days post operation
Secondary	COVID-19 pulmonary complications	Postoperative diagnosis of proven COVID-19 pulmonary complications	30 days post-surgery
Secondary	Duration of hospital stay	Duration of hospital stay (including time spent in intensive care, time ventilated)	30 days post-surgery
Secondary	Pulmonary function	Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale	30 days post-surgery