The University of Southampton and Synairgen, a drug development venture, initiated testing of SNG001, a special inhaled formulation of the naturally occurring antiviral protein interferon beta 1a on patients with COVID-19 back in March. Operating from the hypothesis that the inhaled drug may prevent the worsening of COVID-19 in at-risk patients, the university-led study now will expand the study to include patients at their home in an example of a dynamic and flexible pandemic adjustment moving toward a more patient-centric study. This new trial phase follows approvals necessary to expand from the original 100 patients to include enrolling an additional 120 patients in the home-based study.
The Expanded Trial
By now including patients with symptoms for less than 72 hours and including those that are aged 50 or over, with high risk comorbilidty (e.g. cardiovascular, diabetes, chronic lung infection), or aged 65 or older, these patients are now monitored and assessed via video call and subsequently sent a swab or by courier for self-swabbing. Tested by Synairgen, eligible patients with a positive sample are sent a box containing all necessary equipment, aerosol delivery device, pulse oximeter, thermometer, other consumables and the study medication SNG001 or placebo.
The study estimated completion date is August 31, 2020, with final completion in the spring.
Both the Southampton Clinical Trials Unit and the biotech have teamed to conduct the clinical trial with additional support offered by the primary care delivery team at the NIHR Clinical Research Network Wessex (CRN Wessex). Recruitment for this study depends on the prevalence of the virus in the community and the degree to which the targeted ‘at risk’ patients become infected. The study team believes that this virtual trial design facilitates the need for scale as needed.
A Good Partnership
Lead investigator Professor Tom Wilkinson (University of Southampton) reports that the “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 allows us to gather clinical evidence for SNG001 more quickly, a treatment we believe could play a role in tackling the COVID-19 pandemic.”
The study team expects to be able to report preliminary top line data in July of this year.
Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies, and Ratko Djukanovic.
Tom Wilkinson, MA, Cantab, MBBS, PhD, FRCP, Processor of Respiratory Medicine, University of Southampton, Principal Investigator