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Clinical Trials/jRCT2031210383
jRCT2031210383CompletedNot Applicable

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

Shionogi & Co., Ltd.0 sites3,100 target enrollmentStarted: October 20, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,100
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Single Arm Study
Intervention Model
Single Assignment
Primary Purpose
Prevention Purpose
Masking
Open(masking Not Used)

Eligibility Criteria

Ages
20age 0month 0week old over to No limit (—)
Sex
All

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Investigators

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