Publication date: Nov 11, 2024
Nirmatrelvir/ritonavir (NMV/r) is an oral antiviral treatment for mild to moderate COVID-19. This phase 2/3, double-blind, randomized (1:1) study assessed oral NMV/r 300 mg/100 mg versus placebo every 12 hours for 5 days in high-risk, unvaccinated, nonhospitalized, symptomatic adults with COVID-19 from 343 sites across 21 countries. In testing the primary endpoint of COVID-19‒related hospitalization and all-cause deaths and key secondary endpoints including symptom duration and COVID-19‒related medical visits, Type I error was controlled with prespecified sequential testing and the Hochberg procedure. Among 2113 randomized patients enrolled from July 2021 through December 2021, 1966 (NMV/r, n=977; placebo, n=989) were included in the prespecified analysis population (symptom onset ≤5 days, did not receive monoclonal antibodies). NMV/r significantly reduced times to sustained alleviation (median, 13 vs 15 days; hazard ratio [HR]=1. 27, p
Concepts | Keywords |
---|---|
Antibodies | COVID-19 drug therapy |
Hospitalization | EPIC-HR |
July | nirmatrelvir |
Randomized | ritonavir |
symptoms |
Semantics
Type | Source | Name |
---|---|---|
disease | MESH | COVID-19 |
drug | DRUGBANK | Ritonavir |
disease | IDO | symptom |
disease | MESH | Long Covid |