C5091018 - An Interventional Efficacy And Safety, Phase 3, Randomized, Double-Blind, 3-Arm Study To Investigate Ibuzatrelvir in Adults With Symptomatic COVID-19 Who Are Severely Immunocompromised

Coronavirus Disease 2019 (COVID-19)

Proportion of participants with the composite endpoint of: • COVID-19-related emergency department (ED) visits with administration of supplemental oxygen, COVID-19 antiviral, or intravenous (IV) treatment (eg, hydration, antibiotics, or corticosteroids); COVID-19-related hospitalization; or all-cause mortality by Day 38, or • Evidence of recurrent or persistent SARS-CoV-2 infection, [CCI]

Time to sustained alleviation of all targeted COVID-19 symptoms through Day 38., Proportion of participants with no [CCI], Proportion of participants with evidence of recurrent or persistent SARS-CoV-2 infection, [CCI], Proportion of participants with COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment (eg, hydration, antibiotics, or corticosteroids), COVID-19-related hospitalization, or all-cause mortality through Day 38., Change from baseline in SARS-CoV-2 RNA level in NP or nasal swabs over time., Proportion of participants with SARS-CoV-2 NP or nasal RNA< LLOQ at each time point through Day 38., Proportion of participants with viral rebound in SARS-CoV-2 RNA level in NP or nasal swabs through Day 38 visit (in both virologic responders and regardless of virologic response)., Time to sustained NP or nasal swab SARS-CoV-2 RNA< LLOQ through Day 38., Incidence of treatment-emergent adverse events (TEAEs)., Incidence of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuations.

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