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Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19

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Trial Profile

Multi-Center, Open-Label, Expanded Access Study of Bucillamine in Hospitalized Patients with Severe COVID-19

Status: Not yet recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 21 Sep 2020

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At a glance

  • Drugs Bucillamine (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Acronyms EA-ARISE
  • Sponsors Revive Therapeutics

    • Most Recent Events

    • 21 Sep 2020 New trial record
    • 16 Sep 2020 According to a Revive Therapeutics media release, the resulting data from the EAP will be valuable in supporting the clinical development of Bucillamine.The EAP for compassionate use provides physicians with access to Bucillamine under Revives existing Investigational New Drug (IND) application for COVID-19.
    • 16 Sep 2020 According to a Revive Therapeutics media release, the Companys expanded access protocol (EAP) for compassionate use of Bucillamine in the treatment of COVID-19 received approval from the independent Institutional Review Board (IRB, Advarra, a premier IRB services company).The EAP for compassionate use is being done to complement the Companys Phase 3 COVID-19 study in the U.S. (NCT04504734). Revive expects to have patients enrolled in the United States this month.

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