NCT04386070

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

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,400 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-16
• Primary completion: 2026-12-31
• Completion: 2027-03-01
• First posted: 2020-05-13
• Last updated: 2025-02-20

Locations

9 sites across 2 countries: Nigeria, Rwanda