The University of Southampton and drug development company Synairgen have announced the expansion of the clinical trial of an inhaled drug that could prevent worsening of COVID-19 in those most at risk.
The home setting arm of the trial is now being rolled out beyond the Southampton area, to include people in the majority of the UK. The researchers are looking for individuals who have tested positive for coronavirus and meet eligibility criteria, to participate from their homes.
In March, the University and Synairgen began clinical tests of SNG001, a special, inhaled formulation of the naturally occurring antiviral protein interferon beta 1a on patients with COVID-19.
In May, the team announced the need to recruit an additional 120 people in the home environment. This element of the project is now being expanded across the country to find people either aged 65 or over, or aged 50 and over with a high-risk comorbidity (such as cardiovascular disease, diabetes or a chronic lung condition). Patients must have had symptoms for less than four days.
Those who think they may be eligible to participate are encouraged to visit this link find out how to take part.
Professor Nick Francis, Professor of General Practice at the University of Southampton, commented: “This trial is unique in that we are targeting individuals with risk factors for severe illness, very early on in the course of their infection. By setting up a ‘virtual network’ of study doctors and nurses we are able to recruit, consent, and provide daily monitoring to patients in their own homes, just about anywhere in the UK.
“We have developed robust and efficient systems for screening, consenting, delivery of drug and trial materials, daily monitoring and safety reporting. We are very excited about being able to evaluate this promising drug in such a unique setting. Early treatment may be the key to preventing serious complications, hospitalisations, and death, and we look forward to robustly addressing this important question.”
Daily video calls with a doctor or nurse will be conducted to supervise dosing with the study medication and for the assessment of trial endpoints. All trial supplies, including a pulse oximeter, thermometer, nebuliser and the trial drug, will be delivered directly to the patient, minimising the chance of spreading the virus.
Richard Marsden, CEO of Synairgen, commented: “We are really pleased to expand patient access to this first-of-its-kind trial. Not only does the home setting trial design allow us to test the drug much earlier in the illness, possibly preventing the worsening of symptoms, but it also reduces the infection risk for both patients and front-line workers due to its virtual format. We also believe this novel trial design presents a practical way to utilise SNG001 in a real-world primary care setting.
“The reduced incidence of COVID-19 demonstrates good progress in the battle to bring this disease under control, but a second wave of infection still presents a significant risk to public health. Synairgen’s trial design, and its expansion nationally, lends itself to recruit additional patients more easily, particularly in the event of a second wave of this disease. In the meantime, we are on track to report the results of the 100 patients who have been successfully treated in the hospital setting in July.”
Visits to the trial website for SNG001 have shown that the majority of eligible patients who have completed the online assessment have lived too far from Synairgen’s virus testing laboratory in Southampton for entry into the trial. Synairgen has therefore amended the trial protocol to allow patients from elsewhere in the UK into the trial, provided they have a positive test result from another laboratory e.g. from an NHS testing facility.
NHS COVID-19 testing facilities have seen a significant increase in capacity and turnaround times since the Test and Trace service was launched in May, making it now possible to get a test result within the timeframe required for entry into the home setting arm of Synairgen’s COVID-19 trial.
The design of the home-based trial will not only test the effectiveness of SNG001 on patients identified earlier in the disease progression, but it will also generate valuable experience in the design and practical delivery of a model of remote care for at risk patients in this and future outbreaks.