Long-Acting Antibody Combo Significantly Prevented COVID-19 Disease Progression

U.K.-based AstraZeneca announced today that the combination of two long-acting antibodies known as Evusheld was found to significantly prevented COVID-19 disease progression or related fatality.

In the TACKLE phase 3 clinical study, a single 600mg intramuscular (IM) dose of Evusheld significantly reduced the relative risk of progressing to severe COVID-19 or death (from any cause) by 50% (95% confidence interval [CI] 15, 71; p=0.010) through day 29 compared to placebo in non-hospitalized patients with mild-to-moderate COVID-19 who were symptomatic for seven days or less, the trial's primary endpoint.

In pre-specified analyses of participants who received treatment within three days of symptom onset, Evusheld reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo (95% CI 9, 98), and the risk reduction was 67% (95% CI 31, 84) when participants received Evusheld within five days of symptom onset.  

Evusheld also reduced the risk of respiratory failure, a secondary endpoint, by 72% (95% CI 0.3, 92; nominal p=0·036), with three Evusheld participants (0.7%) versus 11 placebo participants (3%) requiring measures such as mechanical ventilation or extracorporeal membrane oxygenation1.

Moreover, Evusheld was generally well-tolerated in the trial. 

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK, and TACKLE principal investigator, commented in a press release issued on June 8, 2022, "Despite the success of vaccines, many individuals such as older adults, individuals with co-morbidities and those who are immunocompromised, remain at risk for poor outcomes from severe COVID-19."

"Additional options are needed to prevent disease progression and reduce the burden on healthcare systems, especially with the continued emergence of new variants."

"The TACKLE results show that one intramuscular dose of Evusheld can prevent these individuals from progressing to severe COVID-19, with earlier treatment leading to even better results."

The data from this AstraZeneca-funded study have been published in The Lancet Respiratory Medicine on June 7, 2022.

As of June 2, 2022, the U.S. NIH OpenData Portal reported Evusheld in vitro Therapeutic Activity against SARS-CoV-2 virus variants, including BA.x.

Evusheld has marketing authorization in the European Union, Great Britain, and is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US. Evusheld is also being supplied in several countries globally.

Since December 8, 2021, about 1,449,000 Evusheld doses have been shipped in the U.S.

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