The trial of an inhaled drug that could prevent worsening of COVID-19 in those most at risk is to be expanded to dose patients in the home setting.
In March, the University of Southampton and drug development company Synairgen began clinical tests of SNG001, a special, inhaled formulation of the naturally occurring antiviral protein interferon beta 1a on patients with COVID-19.
This new phase follows receipt of the necessary approvals to expand from the original 100 patients, to include enrolling an additional 120 patients in the home environment.
The expanded trial includes patients who have had symptoms for less than 72 hours and are aged 50 or over with a high-risk comorbidity (such as cardiovascular disease, diabetes or a chronic lung condition), or aged 65 and over.
Eligible patients are assessed via video call, and subsequently sent a swab by courier for self-swabbing. These swabs will be tested by Synairgen, and eligible patients with a positive sample will be sent a box containing all necessary equipment, aerosol delivery device, pulse oximeter, thermometer, other consumables and the study medication SNG001/placebo.
The Southampton Clinical Trials Unit from the University of Southampton have joined forces with Synairgen to conduct the clinical trial, with additional support provided by the primary care delivery team at the NIHR Clinical Research Network Wessex (CRN Wessex).
Recruitment for the home setting of the trial will depend on the prevalence of the virus in the community and the degree to which the targeted ‘at risk’ patients become infected. The novel, virtual trial design, means it is readily scalable if necessary.
Professor Tom Wilkinson, professor of respiratory medicine at the University of Southampton and trial chief investigator, commented: “Expansion of the SG016 placebo controlled trial where we will be treating patients at the first sign of COVID-19 symptoms is something of a first and reflects the ingenuity and expertise of Synairgen and our researchers here at the University of Southampton. This novel approach is designed to reduce infection risks for both patients and front-line workers. Critically, it also allows us to gather clinical evidence for SNG001 more quickly, a treatment we believe could play a crucial role in tackling the COVID-19 pandemic.”
Richard Marsden, CEO of Synairgen, commented: “We are really pleased to be able to expand the SG016 trial to patients in the home environment which enables us to test the drug much earlier in the course of the illness. If successful, we would hope to protect the lungs and prevent the development of the severe lower respiratory tract illness which puts the healthcare system under such strain. We have also been pleased with the progress of the SG016 trial in the hospital environment, having dosed 98 of 100 patients, and look forward to announcing top line data in July.”