Panthera is running a double-blind, placebo-controlled trial of AstraZeneca’s AZD7422 TACKLE1 trial at its north Manchester site.
The study is currently enrolling adult patients with mild to moderate COVID-19. The multi-centre trial aims to establish whether the monoclonal antibody treatment prevents disease progression and reduces serious complications of COVID-19 and transmission.
To reduce the possibility of transmission during the trial, Panthera is treating patients in its mobile clinic at its north Manchester site. This unit is rigorously cleaned between visits to protect staff and patients. Panthera’s GCP trained staff follow strict protocols and are equipped with full PPE masks, visors, and clothing.
More than 60% of the patients will be older than 65 years of age or will have medical conditions which place them at high risk of progression to severe COVID-19. All the patients will have confirmed SARS-CoV-2 from testing of a respiratory tract specimen collected within three days prior to the first visit.
All patients taking part in the study will have intensive follow-up including regular check-ups for at least a year after the initial treatment.
Panthera’s north Manchester site was chosen as it is a standalone clinical trial facility, which, when coupled with its mobile clinic unit, offers a very safe clinical setting for patients who have COVID-19. Many clinical trial sites are situated within medical facilities making them inappropriate for patients with COVID-19.
Stuart Young, CEO of Panthera, said: “There is an urgent need to rapidly evaluate treatments in the non-hospitalized setting to prevent disease progression and reduce serious complications of COVID-19 and transmission.
"We are delighted that our site at North Manchester was chosen and that our recently acquired mobile clinic can give patients and staff the protection they deserve whilst undertaking this very important study. We are taking great care at all our sites across the UK to make sure that they are as safe as possible for both volunteers and staff so that clinical trials can continue. This is vital in ensuring that there are new medications available to prevent and treat, not only COVID-19, but the many other conditions which afflict so many people.”
The two long-acting monoclonal antibodies involved in the trial are man-made versions of naturally occurring human antibodies of the immune system.
About Panthera Biopartners – an Independent Site Management Organisation
Panthera Biopartners was founded by Dr Ian Smith – founder of Synexus - and Professor John Lyon – previously senior executive in Covance and serial entrepreneur - to provide CROs and pharma clients with services relating to the recruitment and running of clinical trials at customised clinical trial sites by GCP trained healthcare professionals.
Panthera has a growing network of sites across the UK managing studies in a variety of conditions in both primary care settings and hospital sites running trials in key secondary care conditions such as CNS, oncology, and NASH with specialist investigators.