Simnotrelvir in COVID-19
Trial question
What is the role of early administration of simnotrelvir plus ritonavir in patients with COVID-19?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 1139
1139 patients (466 female, 673 male).
Inclusion criteria: adult patients with mild-to-moderate COVID-19.
Key exclusion criteria: anticipated need for a high-flow nasal cannula, noninvasive ventilation, invasive ventilation, or extracorporeal membranous oxygenation within 48 hours; serious kidney, liver, or acute CVD; and current or expected use of any medications or substances that have substantial drug interactions with cytochrome P-450 3A4.
Interventions
N=573 simnotrelvir plus ritonavir (750 mg of simnotrelvir plus 100 mg of ritonavir BID for 5 days).
N=566 placebo (matching placebo BID for 5 days).
Primary outcome
Time to sustained resolution of COVID-19 symptoms
180.1 hours
216 hours
216.0 hours
162.0 hours
108.0 hours
54.0 hours
0.0 hours
Simnotrelvir plus
ritonavir
Placebo
Significant
decrease ▼
Significantly shorter time to sustained resolution of COVID-19 symptoms (180.1 hours vs. 216 hours; MD -35.8, 95% CI -60.1 to -12.4).
Secondary outcomes
Significantly shorter median time to sustained alleviation of symptoms (120.4 hours vs. 168.3 hours; MD -47.9, 95% CI -69.8 to -24).
Significantly shorter time to respiratory symptoms recovery (168 hours vs. 209.4 hours; MD -41.4, 95% CI -70.7 to -13.3).
No significant difference in time to symptomatic symptoms recovery (47.6 hours vs. 48 hours; MD -0.4, 95% CI -22.1 to 11).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with mild-to-moderate COVID-19, simnotrelvir plus ritonavir was superior to placebo with respect to time to sustained resolution of COVID-19 symptoms.
Reference
Bin Cao, Yeming Wang, Hongzhou Lu et al. Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19. N Engl J Med. 2024 Jan 18;390(3):230-241.
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