Efficacy, Safety, and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Prevention of Symptomatic COVID-19: 15-Month Final Analysis of the PROVENT and STORM CHASER Trials

Myron J Levin ¹, Andrew Ustianowski ², Stephane De Wit ³

⁰University of Colorado School of Medicine, Aurora, CO, USA.

Infectious Diseases and Therapy +

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May 4, 2024

View abstract on PubMed

Summary

AZD7442 (tixagevimab/cilgavimab) demonstrated significant reduction in symptomatic COVID-19 in the PROVENT study. The STORM CHASER study showed a trend towards reduced symptomatic COVID-19, with no severe cases in the AZD7442 group.

Area Of Science

* Infectious Diseases
* Immunology
* Pharmacology

Background

* The phase 3 PROVENT and STORM CHASER studies investigated AZD7442 (tixagevimab/cilgavimab) for COVID-19 prophylaxis.
* This analysis reports the final 15-month outcomes for both pre-exposure and post-exposure prophylaxis.

Purpose Of The Study

* To evaluate the efficacy and safety of AZD7442 for preventing symptomatic and severe coronavirus disease 2019 (COVID-19).
* To assess the long-term effectiveness and safety profile of intramuscular AZD7442.

Main Methods

* PROVENT: Randomized, double-blind, placebo-controlled trial of 300 mg AZD7442 for pre-exposure prophylaxis.
* STORM CHASER: Randomized, double-blind, placebo-controlled trial of 300 mg AZD7442 for post-exposure prophylaxis within 8 days of exposure.
* Both studies monitored participants for symptomatic COVID-19 and adverse events over 15 months.

Main Results

* PROVENT: AZD7442 showed a 76.7% relative risk reduction in symptomatic COVID-19 at primary analysis and 46.3% at 15 months. Severe/critical COVID-19 was reduced by 91.4% by 15 months.
* STORM CHASER: A 43.3% relative risk reduction in symptomatic COVID-19 was observed at 6 months, with no severe/critical cases in the AZD7442 group by 15 months.
* Adverse event rates were similar between AZD7442 and placebo groups in both studies, indicating a favorable safety profile.

Conclusions

* Intramuscular AZD7442 demonstrates long-term safety and efficacy in preventing symptomatic and severe COVID-19, supporting its use for prophylaxis.
* The study provides proof of concept for the long-term benefit of AZD7442 in COVID-19 prevention.

Keywords:

COVID-19 Cilgavimab Clinical trial Monoclonal antibody Prophylaxis Tixagevimab