ACTIV-3-TICO
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
58.0% male
N = 1417
1417 patients (594 female, 823 male)
Inclusion criteria: adult patients 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
89
86
89.0 %
66.8 %
44.5 %
22.3 %
0.0 %
Tixagevimab-cilgavimab
Placebo
No significant difference ↔
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 adult patients 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.
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