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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Disease 2019

In brief

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.

Key facts

Study ID

NCT04347239

Run by

CytoDyn, Inc.

People needed

484

Starts

2020-04-16

Expected to finish

2022-06-15

Last updated by the study team

2025-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adult ≥ 18 years of age at time of screening.
• Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:
• A. Severe Illness:
• Diagnosed with COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent testing within 5 days of screening
• AND
• Symptoms of severe systemic illness/infection with COVID-19:
• At least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress
• AND
• Clinical signs indicative of severe systemic illness/infection with COVID-19, with at least 1 of the following:
• respiration rate (RR) ≥ 30, heart rate (HR) ≥ 125, saturated oxygen (SaO2) <93% on room air or requires > 2L oxygen by nasal canula (NC) in order maintain SaO2 ≥93%, PaO2/FiO2 <300 (ratio of partial pressure of oxygen in arterial blood to fraction of inspired oxygen)
• AND
• None of the following: Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations), Septic shock (defined by systolic blood pressure (SBP) < 90 mm Hg, or Diastolic BP < 60 mm Hg), Multiple organ dysfunction/failure
• B. Critical Illness:
• Diagnosed with COVID-19 by standard RT-PCR assay or equivalent testing within 5 days of screening
• AND
• Evidence of critical illness, defined by at least 1 of the following:
• Respiratory failure defined based on resource utilization requiring at least 1 of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure (in setting of resource limitation)
• OR
• Shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg or requiring vasopressors)
• OR
• Multiple organ dysfunction/failure
• Subject, if intubated, positive end expiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
• Electrocardiogram (ECG) with no clinically significant findings as assessed by the 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 with do-not-resuscitate (DNR) and/or do-not-intubate (DNI) orders or expected to be made DNR/DNI in setting of resource limitations or family wishes.
• Not a candidate for dialysis or continuation of care (or full medical support) in setting of resource limitations.
• Subject on continuous vasopressors (at the dose of norepinephrine >20μg/min and/or vasopressin >0.04 units/kg/min) for >48 hours at time of screening.
• Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
• Inability to provide informed consent or to comply with test requirements
• Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment
• Pregnancy or breast feeding
• Subject participating in another study with for an investigational treatment for COVID-19.
• Note: Subject who were prescribed (1) hydroxychloroquine or chloroquine with or without azithromycin, (2) Remdesivir, (3) convalescent plasma therapy, or (4) immunomodulatory treatments (including but not limited to sarilumab, clazakizumab, tocilizumab, and anakinra) for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents as part of standard-of-care.

Where it is running

• Advanced Cardiovascular, LLC — Alexander City, Alabama, United States
• St. Jude Medical Center — Fullerton, California, United States
• UCLA — Los Angeles, California, United States
• James A. Haley Veterans' Hospital — Tampa, Florida, United States
• Center for Advanced Research & Education (CARE) — Gainesville, Georgia, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• St. Barnabas — Livingston, New Jersey, United States
• Atlantic Health System Hospital — Morristown, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• New York Community Hospital of Brooklyn — Brooklyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Ohio Health — Columbus, Ohio, United States
• Good Samaritan Hospital Corvallis — Corvallis, Oregon, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas — Houston, Texas, United States

Full record on ClinicalTrials.gov

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