A Phase I/III Randomized, Double-blind Study to Evaluate the Safety and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment
The SUPERNOVA Phase I/III trial will evaluate the safety and neutralizing activity of AZD5156 for the prevention of symptomatic COVID-19 in adults and adolescents 12 years of age or older with conditions that cause immune impairment, who are less likely to mount an adequate protective response after COVID-19 vaccination and therefore are at high risk of developing severe COVID-19 if they were to become infected. The trial is designed to establish the safety and efficacy of AZD5156 building on the established generalized safety and efficacy of EVUSHELD, authorized in countries around the world for pre-exposure prophylaxis and treatment of COVID-19.
AZD5156 is an investigational, long-acting antibody combination of cilgavimab, a component of EVUSHELD (tixagevimab and cilgavimab, formerly AZD7442), and a new long-acting monoclonal antibody (mAb), AZD3152. AZD5156 is being developed to have broad neutralizing activity across SARS-CoV-2 strains. In vitro laboratory studies show that it retains neutralization against all known variants to date, including currently circulating Omicron subvariants that other COVID-19 mAbs have reduced or no neutralization activity against.
- The primary endpoints of the trial are safety and neutralizing activity of a single, intramuscular (IM) dose of AZD5156, compared to EVUSHELD for the prevention of COVID-19.
- Conducted at a variety of sites in the US, UK, EU and Asia, the trial intends to enrol participants 12 years of age or older (minimum weight of 40kg) who are immunocompromised; participants are randomised in a 1:1 ratio to receive the treatment or placebo (EVUSHELD).
- Participants will be followed for approximately one year, with SARS-CoV-2 neutralizing antibodies assessed at one, three and six months.
Main Funding Body
