Efficacy and Safety of TY027, a Treatment for COVID-19, in Humans

This is a Phase 3 Multi-Site, Randomised, Placebo Controlled, Double Blind, Single Dose Study of TY027 for Early Treatment of COVID-19. Efficacy and safety of single dose IV infusion of TY027 in COVID-19 patients will be assessed. A total of 1,305 COVID-19 patients will be enrolled. The first 15 patients will be randomised 1:1:1 to receive either (i) a single fixed dose of 1,500 mg TY027, (ii) a single fixed dose of 2,000 mg TY027 or (iii) Placebo (N = 5 per group) for initial safety assessment. This safety assessment will comprise the safety review of clinical signs, adverse events (AEs) and laboratory test results up to Day 3 post-dose. Subsequent patients will be randomised 1:1 to receive either a single fixed dose of 2,000 mg TY027 (2,000 mg TY027 group) or Placebo (Placebo group) (N = 645 per group). All patients will be inpatient for up to 7 days post-dosing and followed up on Days 14 and 28. If a patient becomes clinically well enough for discharge before Day 7, at the discretion of attending physician, collection of subsequent events/parameters such as abbreviated physical examinations, vital signs, clinical laboratory assessments, pharmacodynamic assessment, biomarker assessment, disseminated intravascular coagulation assessment scheduled after discharge will no longer be feasbile. Conversely, if a patient was to be hospitalised beyond 7 days for medically indicated reasons, daily monitoring and medical assessment will continue, with any additional ad hoc sampling to be recorded as unscheduled visit(s). Remote monitoring through a telephone or video call will be performed on days post-discharge as per originally scheduled in schedule of events, as well as on Day 14 while patients are serving their quarantine order or has been discharged home. All discharged patients are to contact the Principal Investigator or the study team as soon as possible should they experience a worsening of their condition, or if they are admitted to hospital for COVID-19-related symptoms, before their Day 28 visit. Final safety and efficacy analysis of all patients will be assessed at the end of the study.