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

NCT04347239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2025-10-15

Study results available
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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.

Conditions

  • Coronavirus Disease 2019

Interventions

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)

Sponsors & Collaborators

  • CytoDyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Jacob Lalezari, MD · CytoDyn, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-16
Primary Completion
2021-10-24
Completion
2022-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347239 on ClinicalTrials.gov