SUPERNOVA
Research type
Research Study
Full title
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
IRAS ID
1006257
Contact name
Joanne Bangs
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-002378-95
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about the safety of a study drug called AZD5156, and to better understand if it may protect people from COVID-19. AZD5156 is made up of a combination of 2 proteins called ‘monoclonal antibodies’ (mAbs) (AZD1061 [cilgavimab] and AZD3152). Antibodies are made by the body to help fight infections. mAbs are made in a lab and act just like antibodies made by the body and are designed as possible medical treatments.
There are 2 parts of this study: Phase I will include healthy people. About 44 healthy people between 18-55 years will take part in this portion of the study. Phase III will include people with conditions that lead to impaired immune systems and will include about 1200 people at least 12 years of age, weighing at least 40kg. The Phase I part of the study will be conducted at 2 sites in the UK and PhIII at approximately 90 sites in approximately 16 countries.
Phase I – Sentinel Safety Cohort
Participants taking part in the Safety Cohort will receive either the study drug or a placebo. Eligible participants will be randomly assigned a study treatment. Participants have a 10-in-11 chance of being given the study drug. All participants will be randomly assigned to one of 2 groups to receive the study drug/placebo in different muscles (Buttock/thigh).
Phase III – Main Cohort
Part A: Eligible participants will be randomly assigned either the study drug or another combination of 2 mAbs, called EVUSHELD. EVUSHELD, also known as AZD7442, is a similar combination of mAbs that is aimed at targeting the SARS-CoV-2 virus in the same way as the study drug (AZD5156). EVUSHELD is approved or authorised for early access/emergency use in over 40 countries worldwide for COVID-19. They will have a 1-in-2 chance of being given the study drug.
Part B: 6 months after the first dose in Part A, eligible participants will enter Part B of the study and will receive the study drug.
Duration for participants will be approximately 12monthsREC name
London - Harrow Research Ethics Committee
REC reference
22/LO/0821
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion