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A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ampligen as therapy for early-onset COVID-19

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Trial Profile

A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ampligen as therapy for early-onset COVID-19

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2021

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At a glance

  • Drugs Rintatolimod (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors AIM ImmunoTech

    • Most Recent Events

    • 30 Sep 2021 New trial record
    • 28 Sep 2021 According to an AIM ImmunoTech media release, the company has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19. This study include exploratory endpoints that could support company's recently filed provisional patent application.

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