Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 (PROTECT-Surg)

August 25, 2021 updated by: University of Birmingham
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)

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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:

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

Enrollment (Anticipated)

6400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumonia free survival; acute respiratory distress syndrome (ARDS) free survival; or death
Time Frame: 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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 14, 2026

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Hospital-level data will not be released or published. Country-level analyses will only be conducted with permission of lead investigators from each participating country. Local investigators may access their data across their country to perform country-level analyses (all participating hospitals should consent to their data being used in this way).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Acute Respiratory Syndrome

Clinical Trials on RESP301

3
Subscribe