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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)


Clinical Trial 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 Design


Related Conditions & MeSH terms

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

NCT number NCT04386070
Study type Interventional
Source University of Birmingham
Contact Donna Smith
Phone +44 (0)121 415 9103
Email PROTECT-Surg@trials.bham.ac.uk
Status Not yet recruiting
Phase Phase 3
Start date October 1, 2021
Completion date May 14, 2026

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