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A Phase I/III Randomized, Double Blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre Exposure Prophylaxis of COVID 19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

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Trial Profile

A Phase I/III Randomized, Double Blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre Exposure Prophylaxis of COVID 19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs AZD-5156 (Primary) ; Sipavibart (Primary) ; Cilgavimab/tixagevimab
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Acronyms SUPERNOVA
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 13 Mar 2025 Status changed from active, no longer recruiting to completed.
    • 09 Jan 2025 According to RQ Bio media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorisation for the medicinal product Kavigale.
    • 01 Jul 2024 According to an AstraZeneca media release, Prof. Paul Loubet is an investigator of this trial.

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