Clinical trial to treat hospitalised patients with covid-19

A new clinical trial led by the University of Warwick and Queen’s University Belfast seeks to find alternatives to ventilators to treat patients who are critically ill with COVID-19.

Researchers will deliver a clinical trial that aims to recruit approximately 4,000 patients in order to find effective alternative solutions for patients with COVID-19 to reduce the need for treatment with a ventilator and improve patient outcomes.

The RECOVERY-RS Respiratory Support trial will compare standard care, intubation and invasive ventilation for critically-ill patients, with other non-invasive treatment methods including masks driven by oxygen or high-flow oxygen through the nose. The comparative data produced will provide a better understanding of which methods are most effective in reducing the need for invasive ventilation and for improving patient outcomes.

The study is based on the theory that non-invasive interventions at an earlier stage may reduce the need for invasive ventilation with a mechanical ventilator. Whilst these treatments are already available in the NHS and have been used for patients with COVID-19, it is not known which approach is the most effective.

The chance to join the trial will be offered to adults who are in patients in NHS hospitals with suspected or confirmed COVID-19. The trial will provide patients with an equal chance of receiving standard care or one of the non-invasive treatments. Which treatment the patient will receive will be decided by a computer at random. Patients will receive all other treatments recommended by their clinical team. The trial will enable researchers to see whether any of the possible new treatments are more or less effective than those currently used for patients with COVID-19.

A recent report estimated that 30% of Covid-19 hospitalised patients are likely to require mechanical ventilation. Mechanical ventilation is termed “invasive” if it involves any instrument inside the trachea through the mouth, such as an endotracheal tube or the neck, such as a tracheostomy tube. Invasive mechanical ventilation requires ventilation equipment as well as staff trained to operate the equipment.

The UK is facing a shortage of both equipment and trained staff to operate the ventilators and therefore it is crucial to find effective, alternative ways to treat patients.

This is a sister trial to the ongoing RECOVERY trial, using a similar infrastructure to enable the fast implementation of the new trial to find effective treatment for COVID-19 patients in Intensive Care Units.

NIHR support has been critical in getting the trial set-up. The study is managed by the Warwick Clinical Trials Unit, part of Warwick Medical School at the University of Warwick, and supported by the NIHR Clinical Research Network. The UK Intensive Care Society has endorsed this as an important trial.

Professor Gavin Perkins, Chief Investigator based at the University of Warwick Clinical Trials Unit, said: “Clinical trials are the only way to safely study these interventions and to offer patients the additional protections necessary within the carefully controlled environment of a clinical trial, and are the best way to quickly find effective supportive interventions for this global pandemic.”

Professor Danny McAuley Chief Investigator based at Queen’s University Belfast said: The unfolding COVID-19 pandemic brings an urgent need for new therapies, particularly for critically ill COVID-19 patients. We simply do not know what treatments are effective for this new disease and we urgently need this trial to test what is the best way to deliver respiratory support as an alternative to ventilators.”

Professor Jeremy Kirk, Clinical Director of the NIHR Clinical Research Network West Midlands said: “Network staff have been closely involved in the set up and running of this important trial, which is the result of outstanding commitment and collaboration from a range of partners. We hope that the results will benefit patients as soon as possible.”

The team leading the trial includes a number of senior and experienced respiratory and critical care clinicians with world class clinical triallists to answer the most pressing questions in relation to supportive care for hospitalised patients with COVID-19.

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