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Clinical Trials Update
July 26, 2022

Evusheld Reduces COVID-19 Disease Severity Among Unvaccinated Adults

JAMA. 2022;328(4):322. doi:10.1001/jama.2022.12178

Tixagevimab plus cilgavimab, a SARS-CoV-2–neutralizing monoclonal antibody combination marketed as Evusheld, protected nonhospitalized individuals with mild to moderate COVID-19 symptoms from progressing to severe COVID-19 or death in a clinical trial. The study, published in The Lancet Respiratory Medicine, is the first to evaluate the intramuscular injection for outpatient treatment; other anti–SARS-CoV-2 monoclonal antibodies must be administered intravenously or subcutaneously.

The international TACKLE trial randomly assigned 910 adults with mild or moderate COVID-19 symptoms to receive a single 300-mg dose of tixagevimab plus a 300-mg dose of cilgavimab or placebo within 7 days of symptom onset. The trial was conducted between January and July 2021, prior to widespread COVID-19 vaccination, and enrolled only unvaccinated people. About 90% of participants were at high risk of severe COVID-19 due to age or comorbidities.

Severe COVID-19 or death occurred in 4% of the 407 participants in the tixagevimab-cilgavimab group, which reported 3 deaths, compared with 9% of 415 participants in the placebo group, which reported 6 deaths. Adverse events were mostly mild or moderate and were more frequent in the placebo group.

Evusheld received US Food and Drug Administration (FDA) Emergency Use Authorization for COVID-19 prevention in December 2021. AstraZeneca is in discussions with the FDA about a new indication for COVID-19 treatment, a spokesperson for the drug manufacturer wrote in an email.

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