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A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection

Trial Profile

A Phase 2/3, Adaptive, Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of Tempol (MBM-02) in Subjects With COVID-19 Infection

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 08 Dec 2022

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At a glance

  • Drugs Tempol (Primary)
  • Indications COVID 2019 infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Adamis Pharmaceuticals Corporation

Most Recent Events

  • 21 Sep 2022 Status changed from recruiting to discontinued, according to an Adamis Pharmaceuticals Corporation media release,
  • 21 Sep 2022 Primary endpoint has not been met. (Difference in the rate of sustained clinical resolution1 of symptoms of COVID-19), according to an Adamis Pharmaceuticals Corporation media release.
  • 21 Sep 2022 According to an Adamis Pharmaceuticals Corporation media release, the independent Data Safety Monitoring Board (DSMB) after third planned interim analysis has recommended to halt study early due to lack of efficacy. The DSMB did note that no safety concerns were identified in the subjects that received Tempol. Based on the recommendation from the DSMB, the Company has halted the trial and will now evaluate the unblinded data from the trial to determine the next developmental steps for Tempol.

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