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BBC Overview
Kaye Flitney is one of 75 people enrolled in the clinical trial.
Preliminary results from a clinical trial suggest that a new treatment for Covid-19 dramatically reduces the number of patients needing intensive care, according to the UK company that developed it.
Synairgen’s treatment, Southampton-based biotechnology, uses a protein called interferon beta that the body produces when it contracts a viral infection.
The protein is inhaled directly into the lungs of coronavirus patients, using a nebulizer, in the hope that it will stimulate an immune response.
Initial findings suggest that the treatment reduced the chances of a Covid-19 patient in the hospital developing a serious illness, such as requiring ventilation, by 79%.
Patients were two to three times more likely to recover to the point where daily activities were not compromised by their illness, Synairgen says.
He said the trial also indicated “very significant” reductions in dyspnea among patients who received the treatment.
Additionally, the average time patients spent in the hospital is said to have been cut by a third, for those who received the new drug, from an average of nine days to six days.
The double-blind trial involved 101 volunteers who had been admitted for treatment at nine UK hospitals for Covid-19 infections.
Half of the participants received the medication, the other half received what is known as a placebo, an inactive substance.
Unconfirmed results
Stock market rules mean that Synairgen is required to report the preliminary results of the trial.
The results have not been published in a peer-reviewed journal, nor have all the data been made available; so the BBC cannot confirm the claims made for the treatment.
But if the results are as the company says, it will be a very important step in the treatment of coronavirus infections.
The scientist in charge of the trial, Tom Wilkinson, says that if the results are confirmed in larger studies, the new treatment will be “a game changer.”
The trial was relatively small, but the signal that the treatment benefits patients was unusually strong, he says.
“We could not have expected much better results than these,” Synairgen CEO Richard Marsden told the BBC.
He described the results as “a breakthrough in the treatment of hospitalized patients with Covid-19”.
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BBC Overview
BBC Justin Rowlatt with nurse Sandy Aitken by a patient’s bed
What happens next?
Marsden said the company will present its findings to medical regulators around the world in the coming days to see what additional information they need to approve the treatment.
That process could take months, although the British government, like many others, has said it will work as quickly as possible to get approval for promising coronavirus treatments.
You may be able to get emergency approval since the antiviral drug remdesivir was in May.
Alternatively, permission may be given for more patients to receive the treatment with carefully monitored effects to confirm that it is safe and effective.
If approved, the drug and nebulizers used to administer it would have to be manufactured in large quantities.
Marsden says it instructed companies to start producing supplies in April to make sure they are available in case the results are positive.
He says he hopes Synairgen can administer “about 100,000” doses a month during the winter.
How does the treatment work?
Interferon beta is part of the body’s first line of defense against viruses, warning you that it expects a viral attack.
The coronavirus appears to suppress its production as part of its strategy to evade our immune system.
The new drug is a special formulation of beta interferon administered directly to the airways through a nebulizer that turns the protein into an aerosol.
The idea is that a direct dose of the protein in the lungs triggers a stronger antiviral response, even in patients whose immune systems are already weak.
Interferon beta is commonly used in the treatment of multiple sclerosis.
Previous clinical trials conducted by Synairgen have shown that it can stimulate an immune response and that patients with asthma and other chronic lung conditions can comfortably tolerate the treatment.
How was the treatment tested?
No one involved in the trial knew which patients had received which treatment until it ended.
“If you know it is a drug, your mind may be biased,” said Sandy Aitken, one of the nurses who administered the new drug to patients at Southampton Hospital.
Synairgen’s drug test was the template for the Accord program, an accelerated clinical trial scheme established by the UK government in April to accelerate the development of new drugs for Covid-19 patients.
Synairgen’s team believes the drug could be even more effective in the early stages of the infection.
A trial exploring the effects of giving patients who are in high-risk groups the new drug as soon as Covid-19 is confirmed to have had trouble finding volunteers because there are so few new infections at the moment.
