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

NCT04343651 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CD10_COVID-19
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Coronavirus Disease 2019

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Total Symptom Score

  Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \[0=none, 1=mild, 2=moderate, and 3=severe\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.

  Clinical Improvement will be assessed at baseline and at EOT (day 14).

Secondary Outcomes (12)

• Time to Clinical Resolution (TTCR)

  Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).

• Incidence of Hospitalization

  From visit 2 (day 0) through day 14 (in days)

• Duration (Days) of Hospitalization

  Total duration of hospitalization between visit 2 (day 0) in days and end of treatment

• Incidence of Mechanical Ventilation

  Total duration of mechanical ventilation since visit 2 (day 0) (days)

• Duration of Mechanical Ventilation Supply

  Duration of mechanical ventilation since visit 2 (day 0) (days

Other Outcomes (4)

• Change in Size of Lesion Area by Chest Radiograph or CT

  Day 14

• Change From Baseline in Serum Cytokine and Chemokine Levels

  Days 3, 7, and 14

• Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages

  Days 3, 7, and 14

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.

Drug: Placebo

700mg Leronlimab

EXPERIMENTAL

Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.

Drug: Leronlimab (700mg)

Interventions

Placebo DRUG

Placebo

Placebo

Leronlimab (700mg) DRUG

Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)

Also known as: PRO 140

700mg Leronlimab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult ≥ 18 years of age at time of enrollment.
• Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
• Mild (uncomplicated) Illness:
• Diagnosed with COVID-19 by a standardized RT-PCR assay AND
• Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND
• No signs of a more serious lower airway disease AND
• RR\<20, HR \<90, oxygen saturation (pulse oximetry) \> 93% on room air
• Moderate Illness:
• Diagnosed with COVID-19 by a standardized RT-PCR assay AND
• In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR
• Signs of moderate pneumonia, including RR ≥ 20 but \<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \> 93% on room air AND
• If available, lung infiltrates based on X-ray or CT scan \< 50% present
• Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
• Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
• Understands and agrees to comply with planned study procedures.

You may not qualify if:

• Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
• History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
• Subjects showing signs of clinical jaundice at the time of screening;
• History of moderate and severe liver disease (Child-Pugh score \>12);
• Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;
• History of severe chronic kidney disease or requiring dialysis;
• Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.
• Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months.
• Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study.
• Patients with malignant tumor, or other serious systemic diseases;
• Patients who are participating in other clinical trials;
• Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible; and
• Inability to provide informed consent or to comply with test requirements

Sponsors & Collaborators

• CytoDyn, Inc.: lead

Study Sites (12)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262-4871, United States

Location

Eisenhower Health

Rancho Mirage, California, 92270, United States

Location

Yale

New Haven, Connecticut, 06510, United States

Location

Center for Advanced Research & Education (CARE)

Gainesville, Georgia, 30501, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Atlantic Health System Hospital

Morristown, New Jersey, 07962-1905, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

White Plains Hospital

White Plains, New York, 10601, United States

Location

Novant Health

Charlotte, North Carolina, 27103, United States

Location

Ohio Health

Columbus, Ohio, 43215, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 39353749 DERIVED

Related Links

• NEWS2 Score

MeSH Terms

Conditions

COVID-19

Interventions

leronlimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Scott Kelly, Chief Medical Officer
• Organization: CytoDyn Inc.

skelly@cytodyn.com

(360) 980-8524

Study Officials

• Angela Ritter, MD

  Center for Advanced Research and Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 13, 2020
• Study Start: April 1, 2020
• Primary Completion: July 21, 2020
• Study Completion: September 20, 2021
• Last Updated: January 4, 2023
• Results First Posted: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)