PROTECT-Surg: Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
Study Details
Study Description
Brief 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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed 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:
- 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control (normal practice) Treatment without the trial intervention. Patients will be treated as per hospital routine practice. The control arm may change over the course of the trial and will be monitored by the TMG and DMC |
|
| Experimental: RESP301 RESP301 is administered quickly (8-10 minutes) via an easy-to-use, vibrating mesh nebuliser. The recommended nebulisers used to administer this intervention are available in all participating countries. The intervention will be administered using a nebuliser according to standard local practice; where permitted for patients to self-administer, a member of the clinical team will ensure that the patient has viewed the intervention administration training video, and will also oversee the patient for the first trial dose to ensure proper administration. |
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.
|
Outcome Measures
Primary Outcome Measures
- Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death [From randomisation until discharge from hospital, average less than 30 days]
The primary outcome is any one of the following, inpatient, postoperative pulmonary complications: Pneumonia Acute respiratory distress syndrome (ARDS) Death
Secondary Outcome Measures
- Rate of Pneumonia [From randomisation until discharge from hospital, average less than 30 days]
Pneumonia will be presented and analysed separately as a secondary outcome measure as well as within the composite primary outcome measure.
- Rate of ARDs [From randomisation until discharge from hospital, average less than 30 days]
ARDs will be presented and analysed separately as a secondary outcome measure
- Death rate [From randomisation until discharge from hospital, average less than 30 days]
Death will be presented and analysed separately as a secondary outcome measure
- Rate of unexpected ventilation [From operation until 30 days post operation]
Unexpected inability to extubate and wean patient from ventilation after general anaesthesia, or reintubation and ventilation by 30 days after surgery
- COVID-19 pulmonary complications [30 days post-surgery]
Postoperative diagnosis of proven COVID-19 pulmonary complications
- Duration of hospital stay [30 days post-surgery]
Duration of hospital stay (including time spent in intensive care, time ventilated)
- Pulmonary function [30 days post-surgery]
Pulmonary function in keeping with the World Health Organisation (WHO) Solidarity Trial outcome scale
Eligibility Criteria
Criteria
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:
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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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Birmingham
- Christian Medical College and Hospital, Ludhiana, India
- Tamale Teaching Hospital, Ghana.
- University of Lagos, Nigeria
- Kigali University Teaching Hospital
- Hospital Español Veracruz
- Université d'Abomey-Calavi
- University of Witwatersrand, South Africa
- University of Edinburgh
- Istituto Clinico Humanitas
- University of Cape Town
Investigators
- Principal Investigator: Aneel Bhangu, University of Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG_20-029 COVID-19
- 2020-001448-24