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A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)

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Trial Profile

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Adintrevimab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms STAMP
  • Sponsors Invivyd

    • Most Recent Events

    • 23 Sep 2024 According to an Invivyd media release, the emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
    • 07 May 2024 According to an Invivyd media release, company announced its intention to submit an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway based on data from Phase 2/3 clinical trial (STAMP) and CANOPY Phase 3 clinical trial.
    • 22 Nov 2022 Status changed from active, no longer recruiting to discontinued.

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