NCT04347239

Evaluate the Efficacy & Safety of Leronlimab in Patients With Severe or Critical COVID-19

A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 484 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

Detailed description

This was a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. A single arm, non-randomized, open-label phase was added to the protocol after completion of enrollment in the randomized phase of the study. The study had three phases: Screening Period, Treatment Period, and Follow-Up Period.

Conditions

• Coronavirus Disease 2019

Interventions

Type	Name	Description
DRUG	Placebo	Placebo
DRUG	Leronlimab (700mg)	Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Timeline

• Start date: 2020-04-16
• Primary completion: 2021-10-24
• Completion: 2022-06-15
• First posted: 2020-04-15
• Last updated: 2025-10-15
• Results posted: 2025-08-27

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study