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Background  Vaccines effectively prevent COVID-19, but some individuals have medical comorbidities or receive therapies that impair their immune response to vaccination, or are ineligible for vaccination. For such individuals who remain at risk of COVID-19, monoclonal antibodies may provide additional rapid protection. AZD7442 comprises 2 fully human extended half-life SARS-CoV-2–neutralizing antibodies that bind distinct epitopes of the viral spike protein receptor binding domain. AZD7442 is in development for the prevention and treatment of COVID-19. Here, we report primary Phase 3 study results of AZD7442 for pre-exposure prophylaxis of symptomatic COVID-19.    Methods  PROVENT (NCT04625725) is a Phase 3, 2:1 randomized, double-blind, placebo-controlled study of a single 300-mg AZD7442 dose (2 intramuscular injections; 150 mg each of tixagevimab and cilgavimab) for symptomatic COVID-19 prevention. Participants were unvaccinated adults (≥ 18 years old) without prior SARS-CoV-2 infection, who may benefit from immunoprophylaxis with antibodies due to an increased risk of either inadequate response to vaccination or SARS-CoV-2 exposure. The primary study endpoints were first case of SARS-CoV-2 RT-PCR-positive symptomatic illness post dose and prior to Day 183 (efficacy), and safety of AZD7442.    Results  In total, 5197 participants (mean age 53.5 years, 46% female) were randomized and dosed (safety analysis set): AZD7442 n=3460; placebo n=1737. In the primary efficacy analysis (full pre-exposure analysis set, n=5172), AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval 46.0, 90.0) vs placebo (P< 0.001) (Table). Adverse events occurred in 35% and 34% of participants administered AZD7442 and placebo, respectively, and injection site reactions occurred in 2.4% and 2.1% of participants, respectively (safety analysis set). There was 1 case of severe/critical COVID-19 and 2 COVID-19–related deaths in the placebo arm.Conclusion  The primary study endpoints were met: a one-time dose of AZD7442 demonstrated statistically significant protection against symptomatic COVID-19 and was well tolerated. AZD7442 is the first long-acting monoclonal antibody combination that represents a potential new option to augment COVID-19 prevention.  PROVENT funding statement imageDisclosures    Myron J. Levin, MD ,  GSK group of companies  (Employee, Research Grant or Support)  Andrew Ustianowski, MBBS ,  Vir/GlaxoSmithKline  (Advisor or Review Panel member)  Stéphane De Wit, MD ,  Gilead  (Grant/Research Support) Janssen  (Grant/Research Support) Merck Sharpe & Dohme  (Grant/Research Support) ViiV Healthcare  (Grant/Research Support)  Odile Launay, MD, PhD ,  AstraZeneca  (Grant/Research Support) GlaxoSmithKline  (Consultant, Grant/Research Support, Other Financial or Material Support, Data safety monitoring board) Johnson & Johnson  (Consultant, Grant/Research Support) Moderna  (Consultant) Pfizer  (Consultant, Grant/Research Support) Sanofi Pasteur  (Consultant, Grant/Research Support)  Miles Avila, MPH, GStat ,  AstraZeneca  (Employee, Shareholder)  Seth Seegobin, PhD ,  AstraZeneca  (Employee, Shareholder)  Alison Templeton, PhD ,  AstraZeneca  (Employee, Shareholder)  Yuan Yuan, PhD ,  AstraZeneca  (Employee, Shareholder)  Philip Ambery, FRCP ,  AstraZeneca  (Employee, Shareholder)  Rosalinda H. Arends, PhD ,  AstraZeneca  (Employee, Shareholder)  Rohini Beavon, PhD ,  AstraZeneca  (Employee, Shareholder)  Karen A. Near, MD ,  AstraZeneca  (Employee, Shareholder)  Kelly W. Padilla, PharmD ,  AstraZeneca  (Employee, Shareholder)  Konstantina Psachoulia, PhD ,  AstraZeneca  (Employee, Shareholder)  Audrey Sharbaugh, PhD ,  AstraZeneca  (Employee, Shareholder)  Katie Streicher, PhD ,  AstraZeneca  (Employee, Shareholder)  Menelas N. Pangalos, PhD ,  AstraZeneca  (Employee, Shareholder)  Mark T. Esser, PhD ,  AstraZeneca  (Employee, Shareholder)  Robert A. Gasser, Jr., MD ,  AstraZeneca  (Employee, Shareholder)

LB5. PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults