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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)

Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral Merimepodib in Combination With Intravenous Remdesivir in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 15 Dec 2020

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At a glance

  • Drugs Merimepodib (Primary) ; Remdesivir (Primary)
  • Indications COVID-19 respiratory infection; Respiratory insufficiency
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors ViralClear Pharmaceuticals
  • Most Recent Events

    • 26 Oct 2020 According to a BioSig Technologies media release, the unblinded SMC detected an imbalance in survival rates in these NIAID Grade 3 patients between the placebo and merimepodib making it unlikely that the trial would meet its primary safety endpoints. The company has therefore elected to stop enrollment into the clinical trial. Patients will be followed as per the protocol for safety monitoring; however, no further study drug treatments will be administered.
    • 26 Oct 2020 According to a BioSig Technologies media release, At the time of the most recent review of the data by the SMC, 44 patients had been enrolled in the trial of whom 42 had received study drug (either merimepodib solution or matching placebo). This most recent review of the data documented all 22 Grade 4 patients were discharged from the hospital and did not relapse during the 37 day follow-up period. Patients who were NIAID Grade 3 patients at the time of enrollment had markedly different outcomes
    • 26 Oct 2020 According to a BioSig Technologies media release, after the implementation of a protocol amendment that expanded the size of the trial, the Safety Monitoring Committee (SMC) was unblinded for safety reasons since these patients are at higher risk for dying from their disease.
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