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A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19

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Trial Profile

A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 25 Mar 2022

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At a glance

  • Drugs APL 9 (Primary)
  • Indications COVID 2019 infections; COVID-19 respiratory infection; Respiratory insufficiency; SARS-CoV-2 acute respiratory disease
  • Focus Adverse reactions
  • Sponsors Apellis Pharmaceuticals

Most Recent Events

  • 04 Mar 2021 According to an Apellis Pharmaceuticals media release, full results will be provided in a scientific forum following completion of the full data analysis, enrollment is complete, and the study reached the last patient visit.
  • 04 Mar 2021 According to an Apellis Pharmaceuticals media release, Interim review by independent data monitoring committee (DMC) found no meaningful reduction in the overall mortality rate in Phase 1/2 study, no safety signals were observed by the DMC following this the company will not pursue additional development of APL-9.
  • 25 Feb 2021 According to an Apellis Pharmaceuticals media release, it expects to report top line data from this trial in the second quarter of 2021

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