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

NCT ID: NCT04343651

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-09-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

700mg Leronlimab

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.

Group Type: EXPERIMENTAL

Leronlimab (700mg)

Intervention Type: DRUG

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

Interventions

Placebo

Placebo

Intervention Type: DRUG

Leronlimab (700mg)

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

Intervention Type: DRUG

Other Intervention Names

PRO 140

Eligibility Criteria

Inclusion Criteria

1. Male or female adult ≥ 18 years of age at time of enrollment.

2. 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

3. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.

4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.

5. Understands and agrees to comply with planned study procedures.

6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices) for the duration of the study.

Exclusion Criteria

1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;

2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy;

3. Subjects showing signs of clinical jaundice at the time of screening;

4. History of moderate and severe liver disease (Child-Pugh score >12);

5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;

6. History of severe chronic kidney disease or requiring dialysis;

7. 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.

8. Patients with malignant tumor, or other serious systemic diseases;

9. Patients who are participating in other clinical trials;

10. 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

11. Inability to provide informed consent or to comply with test requirements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytoDyn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Ritter, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Advanced Research and Education

Locations

University of California, Los Angeles

Los Angeles, California, United States

Palmtree Clinical Research, Inc.

Palm Springs, California, United States

Eisenhower Health

Rancho Mirage, California, United States

Yale

New Haven, Connecticut, United States

Center for Advanced Research & Education (CARE)

Gainesville, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Atlantic Health System Hospital

Morristown, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

White Plains Hospital

White Plains, New York, United States

Novant Health

Charlotte, North Carolina, United States

Ohio Health

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39353749 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2

NEWS2 Score

Other Identifiers

CD10_COVID-19

Identifier Type: -

Identifier Source: org_study_id