Clinical use of AZD7442 as pre-exposure prophylaxis for COVID-19 in the real-world setting – interim analysis of the EVOLVE study

Title : Clinical use of AZD7442 as pre-exposure prophylaxis for COVID-19 in the real-world setting – interim analysis of the EVOLVE study

Abstract:

Background: In response to the COVID-19 pandemic, innovative treatments and preventive measures continue to be pivotal. This interim analysis examines the use of AZD7442, a long-acting antibody (LAAB), as a pre-exposure prophylactic (PrEP) agent against the SARS-CoV-2 virus, aiming to contribute valuable insights into its clinical outcomes in United Arab Emirates and broader applicability.

Methods: This is a multicenter, single-arm, observational prospective study aimed to describe the real-world use of AZD7442 as PrEP against SARS-CoV-2. 408 (87.2%) of the 468 total eligible participants received an initial dose of 600mg, whereas 60 participants (12.8%) received 300mg dose. Participants were followed for up to 12 months to describe COVID-19-related outcomes (medically attended COVID-19, hospitalization, and death), healthcare resource utilization, and quality of life (PROMIS Global-10 for assessing global physical health (GPH), global mental health (GMH) & EQ-5D UK Crosswalk utility). Moreover, data on AEs were collected.

Results: The majority of participants were males (60%) and of Arab ethnicity (73%). Most participants (68.4%) had prior SARS-CoV-2 infection, and the majority (91.5%) were vaccinated with at least one dose of SARS-COV-2 vaccine, 90%, 79%, with two and three doses, respectively, at the study's onset. Following AZD7442 administration, the infection rate of SARS-CoV-2 stood at 3.6%, with 1.7% requiring medical intervention or hospitalization. No COVID-related ICU admissions or COVID-19-related deaths were reported. No adverse events leading to drop-out were reported. Post-enrollment, participants exhibited improvements in both GPH and GMH, as evidenced by T-score elevations at 1, 3, and 6 months. Additionally, EQ-5D UK Crosswalk utility scores displayed marked enhancements in overall health quality following enrollment.

Conclusion: This study underscores the use of AZD7442 as COVID-19 PrEP in a real-world context. The data reveal its utility across a diverse population, including immunocompromised individuals and those with prior vaccination. Notably, it also highlights improvements in physical and mental health post-administration, reinforcing the potential of monoclonal antibodies in COVID-19 prophylaxis.

Funding statement: This study was funded by AstraZeneca FZ LLC.

Biography:

Dr. Nawal Al Kaabi is a pediatrician and infectious diseases consultant. She has been the Chair of the SEHA Infectious Diseases and Infection Control Council since 2012. She served as the Chief Medical Officer at Sheikh Khalifa Medical City and Chair of the Clinical National COVID-19 Committee. Dr. Al Kaabi graduated from the United Arab Emirates University and completed her Fellowships in Pediatrics and Pediatric Infectious Disease in Canada. She is an American Board-Certified Pediatrician, trained in global research at Harvard University, and American Board-certified in Quality. She obtained a Certified Physician certificate from the American Association for Physician Leadership.