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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343651
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

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
Coronavirus Disease 2019 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : April 1, 2020
Estimated Primary Completion Date : December 4, 2020
Estimated Study Completion Date : April 4, 2021

Resource links provided by the National Library of Medicine


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 Name: PRO 140




Primary Outcome Measures :
  1. Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) [ Time Frame: 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) [ Time Frame: Day 14 ]
  2. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: 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) [ Time Frame: Days 3, 7, and 14 ]
  4. Change from baseline in the patient's health status on a 7-category ordinal scale [ Time Frame: 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 [ Time Frame: Day 14 ]
  6. Duration (days) of hospitalization [ Time Frame: Day 14 ]
  7. Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]
  8. Duration (days) of mechanical ventilation supply [ Time Frame: Day 14 ]
  9. Incidence of oxygen use [ Time Frame: Day 14 ]
  10. Duration (days) of oxygen use [ Time Frame: Day 14 ]
  11. Mortality rate [ Time Frame: Day 14 ]
  12. Time to return to normal activity [ Time Frame: Day 14 ]

Other Outcome Measures:
  1. Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
  2. Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
  3. Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
  4. Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343651


Contacts
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Contact: Kush Dhody, MBBS, MS, CCRA 301-956-2536 kushd@amarexcro.com

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Nancy Lopez    310-794-8043    NancyRLopez@mednet.ucla.edu   
Principal Investigator: Otto Yang, MD         
Palmtree Clinical Research, Inc. Not yet recruiting
Palm Springs, California, United States, 92262-4871
Principal Investigator: Richard Loftus, MD         
Eisenhower Health Not yet recruiting
Rancho Mirage, California, United States, 92270
Principal Investigator: Kenneth Lichenstein, MD         
United States, Connecticut
Yale Not yet recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Onyema Ogbuagu, MD         
United States, New Jersey
Atlantic Health System Hospital Not yet recruiting
Morristown, New Jersey, United States, 07962-1905
Principal Investigator: Eric Whitman, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Pam Philippsborn    718-920-5864      
Principal Investigator: Harish Seethamraju, MD         
United States, North Carolina
Novant Health Recruiting
Charlotte, North Carolina, United States, 27103
Contact: Kathleen O'Brien    704-996-7627    kathleen.obrien@novanthealth.org   
Contact: Richards Richards    704-996-7627    pcrichards@novanthealth.org   
Principal Investigator: Michael Morgan, MD         
United States, Ohio
Ohio Health Not yet recruiting
Columbus, Ohio, United States, 43215
Principal Investigator: Kiran Devulapally, MD         
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Marcel Curlin, MD         
Sponsors and Collaborators
CytoDyn, Inc.
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Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT04343651    
Other Study ID Numbers: CD10_COVID-19
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
PRO-140 monoclonal antibody
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents