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Drug trial that could improve respiratory recovery from COVID-19 underway

10/02/2021

This article is from 10 February 2021

A clinical trial has begun to test whether the drug Almitrine can help people who are seriously ill with COVID-19 recover from the disease.

Oxford University Hospitals NHS Foundation Trust is one of three centres taking part in the trial.

Patients suffering from COVID-19 pneumonia often develop very low levels of oxygen, called hypoxia, in the arterial blood supplying the body.

Researchers from the University of Oxford hypothesise that the underlying problem is that the virus disrupts a normal process in the lungs called hypoxic pulmonary vasoconstriction, which diverts blood away from the diseased, non-functional parts of the lung and towards the parts of the lung that are still working properly.

If the lungs are prevented from diverting blood to better-oxygenated lung segments, this can cause the profound hypoxia from which patients with COVID-19 may die. The supportive therapy in hospitals aims to prevent this by using supplementary oxygen and ventilators to support breathing.

Almitrine bismesylate, a drug first developed in France, has been successful in treating acute respiratory distress syndrome by constricting the blood vessels in regions of the lung where the oxygen is low.

Researchers say Almitrine could have the same effect in COVID-19 patients, with the potential to help restore the natural protective process in the lungs and increase oxygen levels in the arterial blood. The trial team hopes that administering this drug to COVID-19 patients will consequently reduce the amount of other respiratory support the patient needs.

The lead researcher is Professor Peter Robbins, Co-Theme Lead for the NIHR Oxford Biomedical Research Centre's Respiratory Theme.

He said: "The primary idea behind medical treatment is that it is supportive - its aim is to keep people alive while they make their recovery from the disease. In a way, you can view the potential support from Almitrine as extending people's individual runway to make a recovery from the disease. The idea behind our trial is to enhance the supportive treatment - extend people's runway."

The clinical trial commenced this week at the Royal Berkshire NHS Foundation Trust in Reading. Almitrine will be administered orally over a seven-day period to determine whether it is effective in reducing the need for other forms of ventilatory support.

Professor Robbins said: "I am pleased about our decision to use oral, rather than intravenous, Almitrine for the trial. This lower tech approach could also be used in low- and middle-income countries which maybe have no, or insufficient, infrastructure to provide oxygen. As an oral drug, it really does have the potential to extend the runway to recovery for many people."

Clinicians aim to recruit around 116 patients across three centres: the Royal Berkshire Hospital, the OUH's John Radcliffe Hospital and University Hospital of Wales in Cardiff. The trial is expected to run for approximately four months.

Nicky Lloyd, Acting CEO of the Royal Berkshire NHS Foundation Trust, said:

"This trial offers a great opportunity to supplement our increasing understanding of COVID-19 and meet the need for new, cost-effective treatments."

OUH Respiratory Consultant Dr Nick Talbot, Chief Investigator for the overall trial across the three sites, added:

"If Almitrine proves beneficial for our patients, we think it would represent a really important new approach in the management of COVID-19."

The trial is supported by a grant from the medical research charity LifeArc, as part of its activities to address the need for new therapies for COVID-19.

"LifeArc has made £22m available to support the global effort against COVID-19, of which £10m has been given to repurposing already available medicines as the fastest route to bring benefit to patients at this critical time," said the charity's CEO, Melanie Lee.