PANORAMIC
Trial question
What is the role of molnupiravir in high-risk vaccinated adults in the community with COVID-19?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 25708
25708 patients (15053 female, 10655 male).
Inclusion criteria: adult patients with relevant comorbidities with confirmed COVID-19 for ≤ 5 days in the community.
Key exclusion criteria: pregnancy; lactation; receipt of molnupiravir; allergy to molnupiravir.
Interventions
N=12774 molnupiravir (molnupiravir at a dose of 800 mg BID for 5 days plus usual care).
N=12934 standard care only (management of symptoms with antipyretics; monoclonal antibodies and antivirals for very high-risk patients).
Primary outcome
Hospitalizations or all-cause mortality at day 28
1%
1%
1.0 %
0.8 %
0.5 %
0.3 %
0.0 %
Molnupiravir
Standard care
only
No significant
difference ↔
No significant difference in hospitalizations or all-cause mortality at day 28 (1% vs. 1%; OR 1.06, 95% CI 0.81 to 1.41).
Secondary outcomes
Significant decrease in days to first reported recovery (9 days vs. 15 days; HR 0.73, 95% CI 0.71 to 0.76).
Significant increase in early sustained recovery (32% vs. 23%; OR 1.62, 95% CI 1.53 to 1.72).
Significant increase in days to alleviation of all symptoms (4 days vs. 4 days; HR 1.18, 95% CI 1.15 to 1.22).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with relevant comorbidities with confirmed COVID-19 for ≤ 5 days in the community, molnupiravir was not superior to standard care only with respect to hospitalizations or all-cause mortality at day 28.
Reference
Christopher C Butler, F D Richard Hobbs, Oghenekome A Gbinigie et al. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. 2023 Jan 28;401(10373):281-293.
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