A Randomized, Open-label, Dose-ranging Study in Adults and Pediatric Individuals ≥ 12 Years of Age to Assess the Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AZD7442, for Pre-exposure Prophylaxis of COVID-19

Summary

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, and Pharmacodynamics of AZD7442, a Combination Product of Two Monoclonal Antibodies (Tixagevimab and Cilgavimab), for Pre-exposure Prophylaxis of COVID-19

Timeline

Start

2022-06-09

Primary completion

2023-10-04

Completion

2023-10-04

Outcome

Outcome not reported

Stopped: “Sponsor terminated after review of FDA's request to halt further dosing (30Mar2023) given that AZD7442 is not active against \>99% of the currently circulating SARS-CoV-2 variants in the USA, the benefit risk assessment may not be favorable”

Drugs

Indications