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Leronlimab (700mg)Wiki

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Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug2006 RS blend Wiki 0.71
drug1952 Pulmozyme Wiki 0.50
drug1860 Placebos Wiki 0.34
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06

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Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 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)

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.

NCT04343651 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)
MeSH:Coronavirus Infections

Primary Outcomes

Description: 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.

Measure: Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough)

Time: Day 14

Secondary Outcomes

Measure: Time to clinical resolution (TTCR)

Time: Day 14

Description: 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.

Measure: Change from baseline in National Early Warning Score 2 (NEWS2)

Time: Days 3, 7, and 14

Measure: Change from baseline in pulse oxygen saturation (SpO2)

Time: Days 3, 7, and 14

Description: 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.

Measure: Change from baseline in the patient's health status on a 7-category ordinal scale

Time: Days 3, 7, and 14

Measure: Incidence of hospitalization

Time: Day 14

Measure: Duration (days) of hospitalization

Time: Day 14

Measure: Incidence of mechanical ventilation supply

Time: Day 14

Measure: Duration (days) of mechanical ventilation supply

Time: Day 14

Measure: Incidence of oxygen use

Time: Day 14

Measure: Duration (days) of oxygen use

Time: Day 14

Measure: Mortality rate

Time: Day 14

Measure: Time to return to normal activity

Time: Day 14

Other Outcomes

Measure: Change in size of lesion area by chest radiograph or CT

Time: Day 14

Measure: Change from baseline in serum cytokine and chemokine levels

Time: Days 3, 7, and 14

Measure: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages

Time: Days 3, 7, and 14

Measure: Change from baseline in CD3+, CD4+ and CD8+ T cell count

Time: Days 3, 7, and 14

2 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)

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.

NCT04347239 Coronavirus Disease 2019 Drug: Placebos Drug: Leronlimab (700mg)
MeSH:Coronavirus Infections

Primary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 28

Time: Day 28

Secondary Outcomes

Description: Day 0 refers to the data of randomization/first treatment.

Measure: All-cause mortality at Day 14

Time: Day 14

Description: 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.

Measure: Change in clinical status of subject at Day 14 (on a 7 point ordinal scale)

Time: Day 14

Description: 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.

Measure: Change in clinical status of subject at Day 28 (on a 7 point ordinal scale)

Time: Day 28

Description: 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

Measure: Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

Time: Day 14


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