Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

Investigator: Eleftherios Mylonakis, MD

Study Coordinator: Diana Avila

Status: Enrolling

ClinicalTrials.gov Number: NCT05605093

Phone: 786.718.8946

Protocol Number: PRO00037446

Description

Brief Summary: Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622, an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi & Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of S-217622 when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.
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