Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19

Phase 2 Completed 86 enrolled CytoDyn, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.

Timeline

Start: 2020-04-01
Primary completion: 2020-07-21
Completion: 2021-09-20

Outcome

Missed primary endpoint

paper No difference was observed in change in total symptom score (P = 0.8184) or other pre-specified secondary endpoints between treatments. PMID 39353749 ↗

registry analysis (superiority test); Placebo vs 700mg Leronlimab; p = 0.818; ANCOVA NCT04343651 ↗

Publications

Seethamraju H, Yang OO, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha JB, Ojha S, Hansen SG, Arman AC, Lalezari JP. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clin Ther. 2024 Nov;46(11):891-899. doi: 10.1016/j.clinthera.2024.08.019. Epub 2024 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Leronlimab	Monoclonal antibody	700 mg	Subcutaneous