Ziresovir in Hospitalized Infants with Respiratory Syncytial Virus Infection.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
26 Sep 2024
26 Sep 2024
Historique:
medline:
25
9
2024
pubmed:
25
9
2024
entrez:
25
9
2024
Statut:
ppublish
Résumé
Respiratory syncytial virus (RSV) is a leading cause of severe illness in infants, with no effective treatment. Results of a phase 2 trial suggested that ziresovir may have efficacy in the treatment of infants hospitalized with RSV infection. In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted in China, we enrolled participants 1 to 24 months of age who were hospitalized with RSV infection. Participants were randomly assigned, in a 2:1 ratio, to receive ziresovir (at a dose of 10 to 40 mg, according to body weight) or placebo, administered twice daily, for 5 days. The primary end point was the change from baseline to day 3 (defined as 48 hours after the first administration) in the Wang bronchiolitis clinical score (total scores range from 0 to 12, with higher scores indicating greater severity of signs and symptoms). The intention-to-treat population included all the participants with RSV-confirmed infection who received at least one dose of ziresovir or placebo; the safety population included all the participants who received at least one dose of ziresovir or placebo. The intention-to-treat population included 244 participants, and the safety population included 302. The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo (-3.4 points [95% confidence interval {CI}, -3.7 to -3.1] vs. -2.7 points [95% CI, -3.1 to -2.2]; difference, -0.8 points [95% CI, -1.3 to -0.3]; P = 0.002). The reduction in the RSV viral load at day 5 was greater in the ziresovir group than in the placebo group (-2.5 vs. -1.9 log Ziresovir treatment reduced signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection. No safety concerns were identified. (Funded by Shanghai Ark Biopharmaceutical; AIRFLO ClinicalTrials.gov number, NCT04231968.).
Sections du résumé
BACKGROUND
BACKGROUND
Respiratory syncytial virus (RSV) is a leading cause of severe illness in infants, with no effective treatment. Results of a phase 2 trial suggested that ziresovir may have efficacy in the treatment of infants hospitalized with RSV infection.
METHODS
METHODS
In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial conducted in China, we enrolled participants 1 to 24 months of age who were hospitalized with RSV infection. Participants were randomly assigned, in a 2:1 ratio, to receive ziresovir (at a dose of 10 to 40 mg, according to body weight) or placebo, administered twice daily, for 5 days. The primary end point was the change from baseline to day 3 (defined as 48 hours after the first administration) in the Wang bronchiolitis clinical score (total scores range from 0 to 12, with higher scores indicating greater severity of signs and symptoms). The intention-to-treat population included all the participants with RSV-confirmed infection who received at least one dose of ziresovir or placebo; the safety population included all the participants who received at least one dose of ziresovir or placebo.
RESULTS
RESULTS
The intention-to-treat population included 244 participants, and the safety population included 302. The reduction from baseline in the Wang bronchiolitis clinical score at day 3 was significantly greater with ziresovir than with placebo (-3.4 points [95% confidence interval {CI}, -3.7 to -3.1] vs. -2.7 points [95% CI, -3.1 to -2.2]; difference, -0.8 points [95% CI, -1.3 to -0.3]; P = 0.002). The reduction in the RSV viral load at day 5 was greater in the ziresovir group than in the placebo group (-2.5 vs. -1.9 log
CONCLUSIONS
CONCLUSIONS
Ziresovir treatment reduced signs and symptoms of bronchiolitis in infants and young children hospitalized with RSV infection. No safety concerns were identified. (Funded by Shanghai Ark Biopharmaceutical; AIRFLO ClinicalTrials.gov number, NCT04231968.).
Identifiants
pubmed: 39321361
doi: 10.1056/NEJMoa2313551
doi:
Substances chimiques
Antiviral Agents
0
Banques de données
ClinicalTrials.gov
['NCT04231968']
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase III
Langues
eng
Sous-ensembles de citation
IM
Pagination
1096-1107Investigateurs
S Zhao
(S)
T Jia
(T)
Y Wu
(Y)
G Zou
(G)
J Z Wu
(JZ)
H Liu
(H)
X Ni
(X)
Y Shang
(Y)
Y Yin
(Y)
Y Zou
(Y)
Y Xu
(Y)
L Zhong
(L)
H Zhang
(H)
H Zhang
(H)
D Zhao
(D)
T Shen
(T)
D Huang
(D)
Q Chen
(Q)
Q Yang
(Q)
Y Yang
(Y)
X Dong
(X)
L Li
(L)
Z Chen
(Z)
E Liu
(E)
L Deng
(L)
W Jiang
(W)
H Cheng
(H)
G Nong
(G)
X Wang
(X)
Y Chen
(Y)
R Ding
(R)
W Zhou
(W)
Y Zheng
(Y)
Z Shen
(Z)
X Lu
(X)
C Hao
(C)
X Zhu
(X)
K Rito
(K)
Informations de copyright
Copyright © 2024 Massachusetts Medical Society.