Antibody Combination Meets Primary Endpoint in Preventing Symptomatic COVID-19

Results from the PROVENT phase 3 pre-exposure prophylaxis trial showed AZD7442 (AstraZeneca) achieved a statistically significant reduction in the incidence of symptomatic COVID-19, which was the trial’s primary endpoint.

AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo, and the trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. Further, there were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. In the placebo arm, there were 3 cases of severe COVID-19, including 2 deaths.

This is the first antibody combination modified to potentially provide long-lasting protection with demonstrated prevention of COVID-19 in a clinical trial, according to AstraZeneca.

The trial included 5197 participants in a 2:1 randomization AZD7442 to placebo, and the primary analysis was based on 5172 participants who did not have SARS-CoV-2 infection at baseline. Further, more than 75% of participants had comorbidities, which include conditions that have been reported to cause a reduced immune response to vaccination.

“The PROVENT data show that 1 dose of AZD7442, delivered in a convenient intramuscular form, can quickly and effectively prevent symptomatic COVID-19,” said Myron J. Levin, MD, professor of pediatrics and medicine and principal investigator on the trial, in a press release. “With these exciting results, AZD7442 could be an important tool in our arsenal to help people who may need more than a vaccine to return to their normal lives.”

Full results from PROVENT will be submitted for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.

REFERENCE

AZD7442 PROVENT Phase 3 prophylaxis trial met primary endpoint in preventing COVID-19. BusinessWire. August 20, 2021. Accessed August 23, 2021. https://www.businesswire.com/news/home/20210820005121/en