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A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection

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Trial Profile

A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 09 Sep 2024

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At a glance

  • Drugs Sulforafan (Primary) ; Sulforafan (Primary)
  • Indications Adult respiratory distress syndrome; COVID-19 pneumonia; COVID-19 respiratory infection; SARS-CoV-2 acute respiratory disease
  • Focus Therapeutic Use
  • Acronyms STAR-Covid19

Most Recent Events

  • 11 Mar 2021 According to an Evgen Pharma media release, the Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy which lead to adjustments to the design of the trial for remaining patients, including in-patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. Initial data will be available during Q2 of the calendar year 2021 and enrollment is expected to complete at the end of 2021/early 20
  • 11 Mar 2021 According to an Evgen Pharma media release, the Data Safety Monitoring Committee ("DMC") concluded that there is no safety concerns after reviewing of the first 60 patients enrolled and recommended to continue trial.
  • 19 Jan 2021 According to an Evgen Pharma media release, the study includes an assessment of safety and futility by a Data Safety and Monitoring Board who will review unblinded data on the first 100 patients treated. An announcement will be made when this point has been reached.

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