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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343651
Recruitment Status : Active, not recruiting
First Posted : April 13, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
CytoDyn, Inc.

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE April 1, 2020
Actual Primary Completion Date July 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2020)
  • Time to clinical resolution (TTCR) [ Time Frame: Day 14 ]
  • 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.
  • Change from baseline in pulse oxygen saturation (SpO2) [ Time Frame: Days 3, 7, and 14 ]
  • 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.
  • Incidence of hospitalization [ Time Frame: Day 14 ]
  • Duration (days) of hospitalization [ Time Frame: Day 14 ]
  • Incidence of mechanical ventilation supply [ Time Frame: Day 14 ]
  • Duration (days) of mechanical ventilation supply [ Time Frame: Day 14 ]
  • Incidence of oxygen use [ Time Frame: Day 14 ]
  • Duration (days) of oxygen use [ Time Frame: Day 14 ]
  • Mortality rate [ Time Frame: Day 14 ]
  • Time to return to normal activity [ Time Frame: Day 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2020)
  • Change in size of lesion area by chest radiograph or CT [ Time Frame: Day 14 ]
  • Change from baseline in serum cytokine and chemokine levels [ Time Frame: Days 3, 7, and 14 ]
  • Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages [ Time Frame: Days 3, 7, and 14 ]
  • Change from baseline in CD3+, CD4+ and CD8+ T cell count [ Time Frame: Days 3, 7, and 14 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019
Intervention  ICMJE
  • Drug: Placebos
    Placebo
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebos
  • Experimental: 700mg Leronlimab
    Intervention: Drug: Leronlimab (700mg)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 10, 2020)
86
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
75
Estimated Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date July 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343651
Other Study ID Numbers  ICMJE CD10_COVID-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party CytoDyn, Inc.
Study Sponsor  ICMJE CytoDyn, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CytoDyn, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP