NCT04343651

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

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: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: CytoDyn, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. 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. The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. A total of 75 subjects will be randomized 2:1 in this study.

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: 2020-04-01
• Primary completion: 2020-07-21
• Completion: 2021-09-20
• First posted: 2020-04-13
• Last updated: 2023-01-04
• Results posted: 2023-01-04

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study