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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Disease 2019

In brief

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.

Key facts

Study ID

NCT04343651

Run by

CytoDyn, Inc.

People needed

86

Starts

2020-04-01

Expected to finish

2021-09-20

Last updated by the study team

2023-01-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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