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c19early.org COVID-19 treatment researchTixagevimab/cilgavimabTixagev../c.. (more..)
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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 86% Improvement Relative Risk Symp. case 76% Tixagevimab/c..  PROVENT  Prophylaxis  DB RCT Is prophylaxis with tixagevimab/cilgavimab beneficial for COVID-19? Double-blind RCT 5,172 patients in multiple countries Fewer symptomatic cases with tixagevimab/cilgavimab (p=0.00046) c19early.org Levin et al., Open Forum Infectious Di.., Dec 2021 Favors tixagevimab/ci.. Favors control

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

Levin et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1646, PROVENT, NCT04625725
Dec 2021  
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36th treatment shown to reduce risk in May 2022
 
*, now known with p = 0.00002 from 15 studies, recognized in 30 countries. Efficacy is variant dependent.
Lower risk for mortality, hospitalization, and cases.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments. c19early.org
PrEP RCT with 3,441 tixagevimab/cilgavimab patients and 1,731 control patients, showing lower risk of symptomatic cases with treatment. Followup data is from fda.gov.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2.75.2, BA.4.6, BQ.1.1 Planas, BA.5, BA.2.75, XBB Haars, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.1 Pochtovyi.
risk of death, 85.7% lower, RR 0.14, p = 0.11, treatment 0 of 3,441 (0.0%), control 2 of 1,731 (0.1%), NNT 866, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of symptomatic case, 76.3% lower, RR 0.24, p < 0.001, treatment 8 of 3,441 (0.2%), control 17 of 1,731 (1.0%), NNT 133.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Levin et al., 8 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, preprint, 19 authors, trial NCT04625725 (history) (PROVENT).
This PaperTixagev../c..All
Abstract: LB5. PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/ Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults Myron J. Levin, MD1; Andrew Ustianowski, MBBS2; Stéphane De Wit, MD3; Odile Launay, MD, PhD4; Miles Avila, MPH, GStat5; Seth Seegobin, PhD5; Alison Templeton, PhD5; Yuan Yuan, PhD6; Philip Ambery, FRCP5; Rosalinda H. Arends, PhD5; Rohini Beavon, PhD5; Karen A. Near, MD5; Kelly W. Padilla, PharmD5; Konstantina Psachoulia, PhD5; Audrey Sharbaugh, PhD5; Katie Streicher, PhD5; Menelas N. Pangalos, PhD5; Mark T. Esser, PhD5; Robert A. Gasser, Jr., MD5; 1University of Colorado Anschutz Medical Campus, Aurora, CO; 2North Manchester General Hospital, Manchester, England, United Kingdom; 3CHU St-Pierre, Brussels, Brussels Hoofdstedelijk Gewest, Belgium; 4Université de Paris, Inserm F-CRIN I-REIVAC, Paris, Ile-de-France, France; 5AstraZeneca, Gaithersburg, Maryland; 6AstraZeneca, Gaithersburg, MD, USA, Gaithersburg, Maryland Session: 55. Late Breaker Abstracts: COVID-19 Treatment & Prophylaxis Thursday, September 30, 2021: 6:15 PM 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 S810 • OFID 2021:8 (Suppl 1) • Late Breaking Abstracts 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 image Disclosures. Myron J. Levin, MD, GSK..
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