Phase 2 study of S-892216 in participants infected with SARS-CoV-2(COVID-19)

Shionogi & Co., Ltd.0 个研究点目标入组 280 人开始时间: 2025年6月6日最近更新: 2025年6月19日

试验速览

暂无简介。

•Must be >= 18 and < 65 years of age at the time of signing the informed consent form (ICF).
•Must weigh >= 40 kg.
•Must have >= 2 of COVID-19 signs/symptoms of mild or higher severity, or >= 1 signs/symptoms of moderate or higher severity, within the 72 hours prior to randomization, and the symptoms must still be present in the 24 hours prior to randomization.
•Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (eg, qRT-PCR) or antigen test from any respiratory tract specimen (eg, oropharyngeal, NP or nasal swab, or saliva), or any other SARS-CoV-2 test approved according to local regulations, collected <= 72 hours (3 days) prior to randomization.
•Oxygenation saturation (SpO2) of >= 92% on room air adjusted for altitude and obtained at rest by study staff within the 24 hours prior to randomization.
•Male or female

•Are at high risk of progression to severe COVID-
•Documented respiratory infection (eg, influenza, respiratory syncytial virus) other than COVID 19 within the 14 days prior to the screening visit.
•History of hospitalization for the current SARS-CoV-2 infection or anticipated need for hospitalization within 24 hours after randomization.
•Received or expected to receive any dose of a SARS-CoV-2 vaccine within 14 days of randomization or during the study through day
•Received or expected to receive any other COVID-19-specific treatment, including outpatient remdesivir, Paxlovid, molnupiravir, monoclonal antibodies (mAbs), ensitrelvir, and convalescent plasma for the current COVID-19 infection.

Change from baseline in SARS-CoV-2 viral RNA level by qRT-PCR (NP swabs) on day 4

未报告次要终点

发起方