ENDURE

• Research type

  Research Study

• Full title

  A Phase II Randomized, Open-label, Multicenter, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, andPharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19

• IRAS ID

  1005861

• Contact name

  Joanne Bangs

• Contact email

  joanne.bangs1@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2022-001014-20

• Clinicaltrials.gov Identifier

  NCT05375760

• Research summary

  The study drug AZD7442, is a combination of 2 monoclonal antibodies, being developed by AstraZeneca AB for the prophylaxis (preventative) treatment of COVID-19. Monoclonal antibodies are made in laboratory, and they act just like the antibodies produced in the body. This means they can help boost the immune system to increase the body’s own ability to protect itself and fight against diseases such as COVID 19. The monoclonal antibodies used in this study are considered experimental, which means they have not been fully tested. A lower dose of these antibodies have been approved in the UK for the Pre-exposure prophylaxis of COVID-19 in adults, however that approval is for a different dosage regimen than what is being investigated in this study.
  The study will enroll adults and paediatric individuals (≥ 12 years of age weighing at least 40 kg) who are moderate to severely immunocompromised due to an underlying disease or are taking immunosuppressive medications and therefore unable to mount an adequate immune response to COVID-19 vaccine.

  Approximately 200 participants who meet the eligibility criteria for the study will be randomised (randomly assigned) in a 1:1 ratio to one of 2 AZD7442 treatment arms:
  • Group A: 600 milligrams (mg) of the study drug on Day 1, followed by 300mg every 3 months for the next 12 months (a total of 5 doses)
  AND
  • Group B: 1200mg of the study drug on Day 1, followed by 600mg after 6 months, and then again 6 months later (a total of 3 doses)
  Participants will be in the study for approximately 2 years. This study is taking place at sites in USA and UK.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  22/LO/0494

• Date of REC Opinion

  12 Aug 2022

• REC opinion

  Further Information Favourable Opinion