An Open-Label Phase 2/3 Study of S-268019 (COVID-19)

Shionogi & Co., Ltd.0 个研究点目标入组 3,100 人开始时间: 2021年10月20日最近更新: 2025年6月20日

试验速览

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•Participant must be >= 20 years of age inclusive, at the time of signing the informed consent.
•Male and female
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

•Positive SARS-CoV-2 antigen test result at Screening.
•Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy
•Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs within 6 months prior to the first dose of study intervention, being treated for malignancy or receiving other immunosuppressive therapy].
•Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).
•Participant has a contraindication to IM injections or blood draws. et, al.

发起方