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Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (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: NCT04347239
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Brief Summary:
The purpose of this study is to assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.

Condition or disease Intervention/treatment Phase
Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg) Phase 2

Detailed Description:

This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebos
Placebos

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)




Primary Outcome Measures :
  1. All-cause mortality at Day 28 [ Time Frame: Day 28 ]
    Day 0 refers to the data of randomization/first treatment.


Secondary Outcome Measures :
  1. All-cause mortality at Day 14 [ Time Frame: Day 14 ]
    Day 0 refers to the data of randomization/first treatment.

  2. Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 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.

  3. Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
    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.

  4. Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
    The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine



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 and older   (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 screening.
  2. Subjects hospitalized with severe or critical illness caused by coronavirus 2019 infection as defined below:

    A. Severe Illness:

    - Diagnosed with COVID-19 by standard 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:

    - RR ≥ 30, HR ≥ 125, SaO2 <93% on room air or requires > 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300

    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 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, 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

  3. Subject, if intubated, positive endexpiratory pressure (PEEP) <15 cmH2O with PaO2/FiO2 >150 mmHg.
  4. Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator
  5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  6. Understands and agrees to comply with planned study procedures.
  7. Women of childbearing potential and their partner must agree to use at least one highly effective method of contraception (e.g., hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the duration of the study.

Exclusion Criteria:

  1. 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.
  2. Not a candidate for dialysis or continuation of care (or full medical support) in setting of resource limitations.
  3. 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.
  4. Subjects who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.
  5. Inability to provide informed consent or to comply with test requirements
  6. Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment
  7. Pregnancy or breast feeding
  8. 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.


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): NCT04347239


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
St. Jude Medical Center Recruiting
Fullerton, California, United States, 92835
Contact: Blanca Sanchez    714-446-5620    Blanca.Sanchez@stjoe.org   
Principal Investigator: David J Park, MD         
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: Nancy Lopez    310-794-8043    NancyRLopez@mednet.ucla.edu   
Principal Investigator: Otto Yang, MD         
United States, Georgia
Center for Advanced Research & Education (CARE) Recruiting
Gainesville, Georgia, United States, 30501
Contact: Julie Recknor    770-534-5154    jrecknor@carega.net   
Principal Investigator: Angela Ritter, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Caitlin Davis    617-735-4466    Cdavis6@bidmc.harvard.edu   
Principal Investigator: Sabrina Tan, MD         
United States, New Jersey
St. Barnabas Recruiting
Livingston, New Jersey, United States, 07052
Principal Investigator: Subroto Paul, MD         
Atlantic Health System Hospital Recruiting
Morristown, New Jersey, United States, 07962-1905
Principal Investigator: Eric Whitman, MD         
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Patty Kiledjian    201-541-6312    pkiledjian@holyname.org   
Principal Investigator: Benjamin De La Rosa, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Jane Wilson    718-920-7916      
Principal Investigator: Harish Seethamraju, MD         
United States, North Carolina
Novant Health Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Kathleen O'Brien       kathleen.obrien@novanthealth.org   
Contact: Pailing Richards    704-996-7627    pcrichards@novanthealth.org   
Principal Investigator: Michael Morgan, MD         
United States, Ohio
Ohio Health Recruiting
Columbus, Ohio, United States, 43215
Principal Investigator: Kiran Devulapally, MD         
United States, Oregon
Oregon Health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Marcel Curlin, MD         
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: Samantha Wang    214-818-2526    Samantha.wang@bswhealth.org   
Principal Investigator: Uriel Sandkovsky         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Hinali Zaveri, MD    713-873-2353    hzaveri@bcm.edu   
Principal Investigator: Kalpalatha Guntupalli, MD         
University of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Jordan Lake    713-500-6767    Jordan.e.lake@uth.tmc.edu   
Principal Investigator: Jordan Lake, MD         
Sponsors and Collaborators
CytoDyn, Inc.
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Responsible Party: CytoDyn, Inc.
ClinicalTrials.gov Identifier: NCT04347239    
Other Study ID Numbers: CD12_COVID-19
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 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