臨床研究等提出・公開システム

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

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

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

May. 31, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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-19.
-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 28.
-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.

Both

COVID-19

Oral administration of S-892216 or placebo

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

+81-3-3881-6116

Mar. 28, 2025

No

The United States