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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. |
|
| 700mg Leronlimab | Experimental | Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Leronlimab (700mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Symptom Score | Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. 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. A negative change from baseline shows an improvement in symptom score. | Clinical Improvement will be assessed at baseline and at EOT (day 14). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Resolution (TTCR) | Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough). Data presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab. The hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138. TTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Size of Lesion Area by Chest Radiograph or CT | Change in size of lesion area by chest radiograph or CT - exploratory endpoint | Day 14 |
| Change From Baseline in Serum Cytokine and Chemokine Levels |
Inclusion Criteria:
Male or female adult ≥ 18 years of age at time of enrollment.
Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:
Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal 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.
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:
Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;
History of severe chronic respiratory disease and requirement for long-term oxygen therapy;
Subjects showing signs of clinical jaundice at the time of screening;
History of moderate and severe liver disease (Child-Pugh score >12);
Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;
History of severe chronic kidney disease or requiring dialysis;
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.
Patients with malignant tumor, or other serious systemic diseases;
Patients who are participating in other clinical trials;
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
Inability to provide informed consent or to comply with test requirements
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| Name | Affiliation | Role |
|---|---|---|
| Angela Ritter, MD | Center for Advanced Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Palmtree Clinical Research, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39353749 | Derived | Seethamraju H, Yang OO, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha JB, Ojha S, Hansen SG, Arman AC, Lalezari JP. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clin Ther. 2024 Nov;46(11):891-899. doi: 10.1016/j.clinthera.2024.08.019. Epub 2024 Sep 30. |
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126 patients were screened, 40 were screen failures.
Participants were enrolled at study sites in the United States. The first participant was randomized on 30-Apr-2020. Data submitted represent analysis performed on data collected after all patients completed the Follow UP period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebos: Placebo Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2020 | Jul 20, 2022 |
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| Drug |
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) |
|
|
| Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough). |
| Incidence of Hospitalization | Number of patients requiring hospitalization | From visit 2 (day 0) through day 14 (in days) |
| Duration (Days) of Hospitalization | Duration of hospitalization in days | Total duration of hospitalization between visit 2 (day 0) in days and end of treatment |
| Incidence of Mechanical Ventilation | Incidence of mechanical ventilation supply | Total duration of mechanical ventilation since visit 2 (day 0) (days) |
| Duration of Mechanical Ventilation Supply | Duration (days) of mechanical ventilation supply | Duration of mechanical ventilation since visit 2 (day 0) (days |
| Incidence of Oxygen Use | Incidence of oxygen use over course of treatment | Use of oxygen since visit 2 (day 0) to end of treatment |
| Duration of Oxygen Use | Duration of oxygen use in days | Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days) |
| Mortality at Day 14 | Incidence of mortality at day 14 | Mortality at EOT (day 14) |
| Time to Return to Normal Activity | Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities" | Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities" |
| Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score). | Baseline to Day 3, 7 and 14 |
| Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values | Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 |
| Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on 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. | Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14) |
Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14
| Days 3, 7, and 14 |
| Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages | Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14 | Days 3, 7, and 14 |
| Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count | Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14 | Days 3, 7, and 14 |
| Palm Springs |
| California |
| 92262-4871 |
| United States |
| Eisenhower Health | Rancho Mirage | California | 92270 | United States |
| Yale | New Haven | Connecticut | 06510 | United States |
| Center for Advanced Research & Education (CARE) | Gainesville | Georgia | 30501 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Atlantic Health System Hospital | Morristown | New Jersey | 07962-1905 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| White Plains Hospital | White Plains | New York | 10601 | United States |
| Novant Health | Charlotte | North Carolina | 27103 | United States |
| Ohio Health | Columbus | Ohio | 43215 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| FG001 | 700mg Leronlimab | Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of leronlimab or placebo and is population used for the analysis of efficacy parameters or measurements.
The Safety Population includes all subjects who received at least one dose of leronlimab or placebo. This population was used for the analysis of safety parameters or measurements. There were 84 subjects in the MITT and Safety Population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebos: Placebo Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. |
| BG001 | 700mg Leronlimab | Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| COVID SYMPTOMS SCORE | Baseline symptoms assessed were fever, myalgia, dyspnea, and cough. Each symptom was graded from 0 to 3 [0=none, 1=mild, 2=moderate, and 3=severe]. The total score is calculated by summing all scores, with a higher score indicating a worse health state. The total score per patient ranged from 0 to 12 points. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Total Symptom Score | Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened. 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. A negative change from baseline shows an improvement in symptom score. | The Modified Intent-to-Treat (mITT) population was defined as the set of subjects who received at least one dose of leronlimab (PRO 140) or placebo. This population was to be used for the analysis of efficacy parameters or measurements. At the time of this report, there were 84 subjects in the mITT population. | Posted | Mean | Standard Deviation | units on a scale | Clinical Improvement will be assessed at baseline and at EOT (day 14). |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clinical Resolution (TTCR) | Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough). Data presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab. The hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138. TTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0. | MITT | Posted | Number | days | Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough). |
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| Secondary | Incidence of Hospitalization | Number of patients requiring hospitalization | MITT | Posted | Number | participants | From visit 2 (day 0) through day 14 (in days) |
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| Secondary | Duration (Days) of Hospitalization | Duration of hospitalization in days | MITT | Posted | Mean | Standard Deviation | days | Total duration of hospitalization between visit 2 (day 0) in days and end of treatment |
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| Secondary | Incidence of Mechanical Ventilation | Incidence of mechanical ventilation supply | MITT | Posted | Count of Participants | Participants | Total duration of mechanical ventilation since visit 2 (day 0) (days) |
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| Secondary | Duration of Mechanical Ventilation Supply | Duration (days) of mechanical ventilation supply | MITT | Posted | Mean | Standard Deviation | days | Duration of mechanical ventilation since visit 2 (day 0) (days |
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| Secondary | Incidence of Oxygen Use | Incidence of oxygen use over course of treatment | MITT | Posted | Count of Participants | Participants | Use of oxygen since visit 2 (day 0) to end of treatment |
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| Secondary | Duration of Oxygen Use | Duration of oxygen use in days | MITT | Posted | Mean | Standard Deviation | days | Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days) |
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| Secondary | Mortality at Day 14 | Incidence of mortality at day 14 | MITT | Posted | Count of Participants | Participants | Mortality at EOT (day 14) |
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| Secondary | Time to Return to Normal Activity | Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities" | MITT | Posted | Number | days | Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities" |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14 | NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring. Change shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score). | MITT | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 3, 7 and 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14 | Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values | MITT | Posted | Mean | Standard Deviation | Mean change in % O2 sat | Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 |
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| Secondary | Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on 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. | MITT | Posted | Mean | Standard Deviation | units on a scale | Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14) |
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| Other Pre-specified | Change in Size of Lesion Area by Chest Radiograph or CT | Change in size of lesion area by chest radiograph or CT - exploratory endpoint | Not Posted | Day 14 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Serum Cytokine and Chemokine Levels | Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14 | Not Posted | Days 3, 7, and 14 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages | Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14 | Not Posted | Days 3, 7, and 14 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count | Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14 | Not Posted | Days 3, 7, and 14 | Participants |
Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebos: Placebo Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. | 0 | 28 | 6 | 28 | 12 | 28 |
| EG001 | 700mg Leronlimab | Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. | 1 | 56 | 5 | 56 | 7 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Liver Abcess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MeDRA 23.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Kelly, Chief Medical Officer | CytoDyn Inc. | (360) 980-8524 | skelly@cytodyn.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2020 | Jul 20, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
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| C420063 | leronlimab |
Not provided
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Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Baseline symptom score greater than 4 |
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| Units | Counts |
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| Participants |
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| 700mg Leronlimab |
Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections. Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) |
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| OG001 | 700mg Leronlimab | Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5) Patients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection. Male or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below: Mild (uncomplicated) Illness:
Moderate Illness:
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator. |
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