#Antiviral efficacy of oral #ensitrelvir versus oral ritonavir-boosted #nirmatrelvir in #COVID19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial
Summary Background Ensitrelvir is an oral antiviral treatment for COVID-19 with the same molecular target (the main protease ) as ritonavir-boosted nirmatrelvir —the current oral first-line treatment. We aimed to compare the clinical antiviral effects of the two drugs. Methods In an open-label, phase 2, randomised, controlled, adaptive pharmacometric platform trial, low-risk adult outpatients aged 18–60 years with early symptomatic COVID-19 (<4 days of symptoms) were recruited from hospital acute respiratory infection clinics in Thailand and Laos . Patients were randomly assigned in blocks (block sizes depended on the number of interventions available) to one of eight treatment groups, including oral ensitrelvir and oral ritonavir-boosted nirmatrelvir at standard doses, both given for 5 days, and no study drug. The primary endpoint was the oropharyngeal SARS-CoV-2 viral clearance rate assessed between day 0 and day 5 in the modified intention-to-treat population (defined as pa...