Update on STORM CHASER trial assessing AZD 7442 in post-exposure prevention of symptomatic COVID-19.- AstraZeneca.

 Trial participants were unvaccinated adults 18 years and over with confirmed exposure to a person with a case of the SARS-CoV-2 virus within the past eight days. In the overall trial population, AZD 7442 reduced the risk of developing symptomatic COVID-19 by 33% (95% confidence interval (CI): -26, 65) compared to placebo, which was not statistically significant. The trial included 1,121 participants in a 2:1 randomisation AZD 7442 to placebo, with 23 cases of symptomatic COVID-19 accrued in the AZD 7442 arm (23/749) and 17 cases accrued in the placebo arm (17/372). All participants had a negative SARS-CoV-2 antibody test on the day of dosing to exclude prior infection, and a nasopharyngeal swab was also collected and subsequently analysed for SARS-CoV-2 by RT-PCR to detect virus. Given the importance of finding therapies for COVID-19 and to help interpret trial results during the pandemic, additional analyses were performed and are being communicated. In a pre-planned analysis of SARS-CoV-2 PCR positive (detectable virus) and PCR negative (no detectable virus) participants, AZD 7442 reduced the risk of developing symptomatic COVID-19 by 73% (95% CI: 27, 90) compared with placebo, in participants who were PCR negative at time of dosing. In a post-hoc analysis, in participants who were PCR negative at baseline, AZD 7442 reduced the risk of developing symptomatic COVID-19 by 92% (95% CI: 32, 99) versus placebo more than seven days following dosing, and by 51% (95% CI: -71, 86) up to seven days following dosing. Myron J. Levin, MD, Professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the trial, said: “The results of STORM CHASER suggest that AZD 7442 may be useful in preventing symptomatic COVID-19 in individuals not already infected. The PROVENT trial will give us more clarity in this patient population. While COVID-19 vaccination efforts have been successful, there is still a significant need for prevention and treatment options for certain populations, including those unable to be vaccinated or those who may have an inadequate response to vaccination.”