EVUSHELD™ significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations
Pre-exposure prophylaxis (prevention) trial reduced risk of symptomatic COVID-19, with no severe disease or COVID-19-related deaths in EVUSHELD group
Data published in the New England Journal of Medicine
Excerpt from the Press Release:
WILMINGTON, Del.–(BUSINESS WIRE)–Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s EVUSHELD™(tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six-month follow-up analysis, compared to placebo.1 There were no cases of severe disease or COVID-19 related deaths in the EVUSHELD group through the six-month follow-up.1
More than 75% of PROVENT participants at baseline had co-morbidities that put them at high risk for severe COVID-19 if they were to become infected, including people who are immunocompromised and may have an inadequate immune response to vaccination.1
Additional pharmacokinetic data showed that EVUSHELD concentrations remained elevated in serum for six months after administration, supporting that a single dose could provide long-term protection against COVID-19 lasting at least six months.1
The data were published online today in the New England Journal of Medicine.
Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and PROVENT principal investigator on the trial, said: “While COVID-19 vaccines have been highly effective at reducing hospitalization and death, cases continue to surge and many individuals remain at high risk, including immunocompromised individuals and those who cannot be vaccinated. These important data now published in the New England Journal of Medicine provide confidence that one easily administered intramuscular dose of EVUSHELD couldprovide vulnerable populations long-lasting protection. In addition, EVUSHELD has been shown to neutralize BA.2, currently the dominant circulating COVID-19 variant.”
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