6/28/23, 12:00 AM ACTIV-3-TICO Pathway Feedback Search Clinical Topics Home Studies ACTIV 3 TICO ACTIV 3 TICO Disease COVID 19 infection Trial question What is the role of tixagevimab-cilgavimab in patients hospitalized with COVID-19 infection? Study design Multi-center Double blinded RCT Population Characteristics of study participants 42.0% female N = 1417 58.0% male 1417 patients (594 female, 823 male) Inclusion criteria: adults with symptoms for up to 12 days and hospitalized for COVID-19 Key exclusion criteria: receipt of invasive mechanical ventilation; ECMO; vasopressor therapy; mechanical circulatory support; new RRT Interventions N=710 tixagevimab-cilgavimab (an intravenous infusion of tixagevimab 300 mg and cilgavimab 300 mg) N=707 placebo (matching placebo) Primary outcome Rate of sustained clinical recovery up to day 90 https://web.pathway.md/studies/rec5Bo7hv1httteTY 1/2 6/28/23, 12:00 AM ACTIV-3-TICO Pathway 89.0 % 89 86 66.8 % 44.5 % 22.3 % No significant difference 0.0 % Tixagevimab-cilgavimab Placebo No significant difference in the rate of sustained clinical recovery up to day 90 (89% vs. 86%; RR 1.08, 95% CI 0.97 to 1.2) Secondary outcomes No significant difference in sustained recovery at day 90 among patients with negative anti-spike neutralizing antibody (85% vs. 82%; RR 1.14, 95% CI 0.97 to 1.34) Significant decrease in the rate of death up to day 90 (9% vs. 12%; HR 0.7, 95% CI 0.5 to 0.97) No significant difference in sustained recovery at day 90 among patients with positive anti-spike neutralizing antibody (90% vs. 88%; RR 1, 95% CI 0.86 to 1.15) Safety outcomes No significant difference in serious adverse events. Significant differences in composite safety outcome of death, serious adverse events, incident organ failure, and serious co-infection through day 90 (25% vs. 30%). Conclusion In adults with symptoms for up to 12 days and hospitalized for COVID-19, tixagevimab-cilgavimab was not superior to placebo with respect to the rate of sustained clinical recovery up to day 90. Reference ACTIV- Therapeutics for Inpatients with COVID- (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022 Oct;10(10):972-984. Open reference URL https://web.pathway.md/studies/rec5Bo7hv1httteTY 2/2