COMET-TAIL
Trial question
Is sotrovimab 500 mg intramuscular injection noninferior to intravenous administration in patients with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 754
754 patients (405 female, 349 male).
Inclusion criteria: patients, aged ≥ 12 years, with COVID-19 who were neither hospitalized nor receiving supplemental oxygen but were at high risk for progression.
Key exclusion criteria: hospitalization or likely requiring hospitalization within 24 hours; severe COVID-19.
Interventions
N=376 intramuscular sotrovimab (single 500 mg intramuscular infusion).
N=378 intravenous sotrovimab (single 500 mg intravenous infusion).
Primary outcome
Rate of progression to all-cause hospitalization for > 24 hours for acute management of illness or all-cause death through day 29
2.7%
1.3%
2.7 %
2.0 %
1.4 %
0.7 %
0.0 %
Intramuscular
sotrovimab
Intravenous
sotrovimab
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of progression to all-cause hospitalization for > 24 hours for acute management of illness or all-cause death through day 29 (2.7% vs. 1.3%; AD 1.06%, 95% CI -1.15 to 3.26).
Secondary outcomes
No significant difference in hospitalization, emergency department visit, or death (3.2% vs. 2.4%; AD 0.86%, 95% CI -1.56 to 3.28).
Significant increase in mean viral load in nasal secretions (25.96 log10 copies/mL vs. 25.03 log10 copies/mL; Ratio 1.04, 90% CI 1 to 1.07).
Safety outcomes
No significant difference in adverse events through week 12.
Conclusion
In patients, aged ≥ 12 years, with COVID-19 who were neither hospitalized nor receiving supplemental oxygen but were at high risk for progression, intramuscular sotrovimab was noninferior to intravenous sotrovimab with respect to the rate of progression to all-cause hospitalization for > 24 hours for acute management of illness or all-cause death through day 29.
Reference
Adrienne E Shapiro, Elias Sarkis, Jude Acloque et al. Intramuscular vs Intravenous SARS-CoV-2 Neutralizing Antibody Sotrovimab for Treatment of COVID-19 (COMET-TAIL): A Randomized Noninferiority Clinical Trial. Open Forum Infect Dis. 2023 Jul 14;10(8):ofad354.
Open reference URL