AIRFLO
Trial question
What is the role of ziresovir in infants and young children hospitalized with RSV infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 244
244 patients (64 female, 180 male).
Inclusion criteria: children 1-24 months of age hospitalized with RSV infection.
Key exclusion criteria: HIV positivity; concurrent influenza virus infection or bacterial pneumonia; known or suspected primary immunodeficiency disease.
Interventions
N=164 ziresovir (at a dose of 10-40 mg according to body weight administered BID for 5 days).
N=80 placebo (matching placebo administered BID for 5 days).
Primary outcome
Reduction in Wang Bronchiolitis Clinical Score at day 3
3.4 points
2.7 points
3.4 points
2.5 points
1.7 points
0.8 points
0.0 points
Ziresovir
Placebo
Significant
increase ▲
Significantly greater reduction in Wang Bronchiolitis Clinical Score at day 3 (3.4 points vs. 2.7 points; AD 0.8 points, 95% CI 0.3 to 1.3).
Secondary outcomes
Significantly greater reduction in RSV viral load at day 5 (2.5 log10 copies/mL vs. 1.9 log10 copies/mL; AD 0.6 log10 copies/mL, 95% CI 0.2 to 1.1).
Significantly greater reduction in least-square mean Wang Bronchiolitis Clinical Score ≥ 8 at day 3 (4.9 points vs. 3.9 points; AD 1 points, 95% CI 0.1 to 1.8).
No significant difference in symptom remission at day 3 (13% vs. 6%; OR 2.04, 95% CI 0.73 to 5.71).
Safety outcomes
No significant differences in adverse events, serious adverse events.
Conclusion
In children 1-24 months of age hospitalized with RSV infection, ziresovir was superior to placebo with respect to reduction in Wang Bronchiolitis Clinical Score at day 3.
Reference
Shunying Zhao, Yunxiao Shang, Yong Yin et al. Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection. N Engl J Med. 2024 Sep 26;391(12):1096-1107.
Open reference URL