A Multicenter, Phase III Randomized, Double-blind, Placebo-Controlled, Outpatient study to Evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 AT-527 in Patients With Mild or Moderate COVID-19

Rebecca Saenz, M.D., Ph.D.0 个研究点目标入组 1,386 人开始时间: 2021年5月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Age >=18 years (regardless of weight) or age >=12 to <18 under (weight >=40 kg ) at the time of signing informed consent (and assent)
•- At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea
•- Positive SARS-CoV-2 diagnostic test withoin72 hours prior to randomization
•- Symptoms consistent with mild or moderate COVID-19 with onset within 5 days before randomization
•- For women of childbearing potential: agreement to remain abstinent or use adequate contraception during the study duration

•- Admitted to a hospital prior to randomization at randomization due to COVID-19
•- Is likely to experience imminent deterioration and require hospitalization
•- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
•- Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 within the last 2 weeks prior to the screening visit
•- Concomitant use of P-glycoprotein inhibitors or inducers
•- Abnormal laboratory test results at screening

发起方

Rebecca Saenz, M.D., Ph.D.