What question did this study set out to answer?

To evaluate the effectiveness of ensitrelvir in improving clinical recovery for hospitalized adults with COVID-19.

April 24, 2026Clinical Infectious Diseases1 citations

Ensitrelvir for the treatment of hospitalized adults with COVID-19: an international phase 3 randomized placebo-controlled trial

JBJason V. BakerUniversity of Minnesota LSLianne Siegel MLMarcelo LossoHospital Ramos Mejía

Key Points

To evaluate the effectiveness of ensitrelvir in improving clinical recovery for hospitalized adults with COVID-19.
Conducted an international phase 3 randomized placebo-controlled trial on hospitalized adults with COVID-19.
Compared ensitrelvir treatment against standard of care (SOC) with placebo control.
No significant improvement in clinical recovery was observed with ensitrelvir addition to SOC.
Confounding factors included lower illness severity during the Omicron era and high concurrent use of remdesivir and corticosteroids.

Abstract

Ensitrelvir treatment did not improve clinical recovery in addition to SOC for adults hospitalized for COVID-19. The lower illness severity in the Omicron era compared to earlier periods in the COVID-19 pandemic, and high use of remdesivir and corticosteroids, may have contributed to the lack of clinical benefit.

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