6/30/23, 2:15 AM TACKLE Pathway Feedback Search Clinical Topics Home Studies TACKLE TACKLE Disease COVID 19 infection Trial question What is the role of tixagevimab-cilgavimab in non-hospitalized adults with mild to moderate COVID- 19 infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 50.0% female N = 903 50.0% male 903 patients (455 female, 448 male) Inclusion criteria: non-hospitalized adults with mild to moderate COVID-19 who were not vaccinated Key exclusion criteria: history of hospitalization or currently hospitalized for COVID-19; a current need for hospitalization or immediate medical attention in a clinic or emergency room service Interventions N=452 tixagevimab-cilgavimab (intramuscular injection at a dose of 600 mg) N=451 placebo (intramuscular injection of 0.9% sodium chloride) Primary outcome https://web.pathway.md/studies/recdpM4rQqUeoxbCi 1/2 6/30/23, 2:15 AM TACKLE Pathway Severe COVID-19 or death 9.0 % 9 6.8 % 4.5 % 4 Significant decrease 2.3 % NNT = 20 0.0 % Tixagevimab-cilgavimab Placebo Significant decrease in severe COVID-19 or death (4% vs. 9%; ARD -4.5, 95% CI -1.1 to -8) Secondary outcomes Significant decrease in prevention of respiratory failure (1% vs. 3%; ARD -2, 95% CI -3.87 to -0.13) Safety outcomes No significant difference in adverse events. Conclusion In non-hospitalized adults with mild to moderate COVID-19 who were not vaccinated, tixagevimab- cilgavimab was superior to placebo with respect to severe COVID-19 or death. Reference Hugh Montgomery, F D Richard Hobbs, Francisco Padilla et al. Efficacy and safety of intramuscular administration of tixagevimab cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2022 Oct;10(10):985-996. Open reference URL https://web.pathway.md/studies/recdpM4rQqUeoxbCi 2/2