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A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

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Trial Profile

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2025

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications COVID 2019 infections; Respiratory insufficiency
  • Focus Proof of concept; Therapeutic Use
  • Sponsors CytoDyn

Most Recent Events

  • 30 Sep 2025 According to a CytoDyn media release, based on the positive data presented at ESMO, company will shortly submit a follow-up phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. Company look forward to sharing more details after the FDA review of the protocol and briefing package that provides a complete summary of company oncology data.
  • 02 Aug 2021 Primary endpoint (Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)) has not been met, according to a CytoDyn media release.
  • 23 Sep 2020 According to a CytoDyn media release, this study has been selected for an oral presentation at the upcoming Special isirv-Antiviral Group Conference on Therapeutics for COVID-19.The Conference is sponsored by the International Society for Influenza and other Respiratory Virus Diseases, an independent and international scientific professional society promoting the prevention, detection, treatment, and control of influenza and other respiratory virus disease.

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