Phase 2a Study to Evaluate Safety and Effectiveness of Ratutrelvir and Standard Treatment in Adults With Mild to Moderate COVID-19

What this Trial Is About

Researchers are evaluating Ratutrelvir 83-0060, a drug that inhibits the main protease of SARS-CoV-2, along with Paxlovid Nirmatrelvir plus Ritonavir, to understand their safety and effectiveness in adults with mild to moderate COVID-19 who are not hospitalized. This open-label, randomized Phase 2a study aims to determine a safe and effective dose of Ratutrelvir and compare it with standard care, providing important information on how these treatments may help manage COVID-19 symptoms and recovery. Participants will be assigned to receive either Ratutrelvir or Paxlovid alongside standard care. The study is multicenter and open-label, meaning both researchers and participants know which treatment is given. The trial includes an experimental group receiving Ratutrelvir, a comparator group receiving Paxlovid, and a non-randomized group receiving Ratutrelvir. Treatment is given during the study period, and the research team monitors the drugs concentration in the blood to understand how it behaves in the body. During the 28-day study period, participants will be closely monitored for safety based on the occurrence and severity of any adverse events. The team will assess how long it takes for COVID-19 symptoms to improve and recover fully. Blood samples will be collected up to day 11 to analyze drug levels. Participants will undergo symptom evaluations regularly, and their health will be tracked throughout the study to ensure safety and gather data on treatment effects.

Early-stage Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19