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A Phase II multicenter, randomized, double-blind, placebo controlled study evaluating the efficacy, safety and tolerability of Estetrol in hospitaised patients with moderate Covid-19 (i.e., not on high flow oxygen or mechanical ventilation)

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Trial Profile

A Phase II multicenter, randomized, double-blind, placebo controlled study evaluating the efficacy, safety and tolerability of Estetrol in hospitaised patients with moderate Covid-19 (i.e., not on high flow oxygen or mechanical ventilation)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Nov 2021

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At a glance

  • Drugs Estetrol (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms Coronesta
  • Sponsors Mithra Pharmaceuticals

Most Recent Events

  • 25 Sep 2021 According to trial design North American Menopause Society 2021 Annual Meeting, an additional 130 patients will be enrolled into Part B. When analysis of Part A data is complete, the 2-part design will allow the Sponsor to make an early decision to proceed to a confirmatory trial including the planned 130 patients from Part B as a distinct cohort in the Phase 3 study, aiming to obtain approval for an effective treatment for COVID-19 as quickly as possible.
  • 25 Sep 2021 Results presented at the North American Menopause Society 2021 Annual Meeting.
  • 17 Jun 2021 According to a Mithra Pharmaceuticals media release, positive DSMB1 assessment from a safety perspective, allowing the trial to proceed: top-line data expected Summer 2021

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