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

Sponsor
CytoDyn, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04343651
Collaborator
(none)
86
Enrollment
12
Locations
2
Arms
17.6
Actual Duration (Months)
7.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebos
  • Drug: Leronlimab (700mg)
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jul 21, 2020
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebos
Placebo
Experimental: 700mg Leronlimab

Drug: Leronlimab (700mg)
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Other Names:
  • PRO 140

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [Day 14]

      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.

    Secondary Outcome Measures

    1. Time to clinical resolution (TTCR) [Day 14]

    2. Change from baseline in National Early Warning Score 2 (NEWS2) [Days 3, 7, and 14]

      This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.

    3. Change from baseline in pulse oxygen saturation (SpO2) [Days 3, 7, and 14]

    4. Change from baseline in the patient's health status on a 7-category ordinal scale [Days 3, 7, and 14]

      A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Lower scores mean a worse outcome.

    5. Incidence of hospitalization [Day 14]

    6. Duration (days) of hospitalization [Day 14]

    7. Incidence of mechanical ventilation supply [Day 14]

    8. Duration (days) of mechanical ventilation supply [Day 14]

    9. Incidence of oxygen use [Day 14]

    10. Duration (days) of oxygen use [Day 14]

    11. Mortality rate [Day 14]

    12. Time to return to normal activity [Day 14]

    Other Outcome Measures

    1. Change in size of lesion area by chest radiograph or CT [Day 14]

    2. Change from baseline in serum cytokine and chemokine levels [Days 3, 7, and 14]

    3. Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [Days 3, 7, and 14]

    4. Change from baseline in CD3+, CD4+ and CD8+ T cell count [Days 3, 7, and 14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

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

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

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

    4. 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.

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

    2. Patients who are participating in other clinical trials;

    3. 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

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Los Angeles Los Angeles California United States 90095
    2 Palmtree Clinical Research, Inc. Palm Springs California United States 92262-4871
    3 Eisenhower Health Rancho Mirage California United States 92270
    4 Yale New Haven Connecticut United States 06510
    5 Center for Advanced Research & Education (CARE) Gainesville Georgia United States 30501
    6 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    7 Atlantic Health System Hospital Morristown New Jersey United States 07962-1905
    8 Montefiore Medical Center Bronx New York United States 10467
    9 White Plains Hospital White Plains New York United States 10601
    10 Novant Health Charlotte North Carolina United States 27103
    11 Ohio Health Columbus Ohio United States 43215
    12 Oregon Health and Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • CytoDyn, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CytoDyn, Inc.
    ClinicalTrials.gov Identifier:
    NCT04343651
    Other Study ID Numbers:
    • CD10_COVID-19
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CytoDyn, Inc.
    COVID-19
    Additional relevant MeSH terms:
    COVID-19
    Coronavirus Infections
    Leronlimab

    Study Results

    No Results Posted as of Sep 29, 2021