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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Placebo
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
University of California, Los Angeles
Los Angeles, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Eisenhower Health
Rancho Mirage, California, United States
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.
Time frame: Clinical Improvement will be assessed at baseline and at EOT (day 14).
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.
Time frame: 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
Time frame: From visit 2 (day 0) through day 14 (in days)
Duration (Days) of Hospitalization
Duration of hospitalization in days
Time frame: Total duration of hospitalization between visit 2 (day 0) in days and end of treatment
Incidence of Mechanical Ventilation
Incidence of mechanical ventilation supply
Time frame: Total duration of mechanical ventilation since visit 2 (day 0) (days)
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Yale
New Haven, Connecticut, United States
Center for Advanced Research & Education (CARE)
Gainesville, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Atlantic Health System Hospital
Morristown, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
White Plains Hospital
White Plains, New York, United States
Novant Health
Charlotte, North Carolina, United States
...and 2 more locations
Duration of Mechanical Ventilation Supply
Duration (days) of mechanical ventilation supply
Time frame: Duration of mechanical ventilation since visit 2 (day 0) (days
Incidence of Oxygen Use
Incidence of oxygen use over course of treatment
Time frame: Use of oxygen since visit 2 (day 0) to end of treatment
Duration of Oxygen Use
Duration of oxygen use in days
Time frame: 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
Time frame: 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"
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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)