The purpose of this study was assess the safety and efficacy of leronlimab (PRO 140) administered as weekly subcutaneous injection in subjects with severe or critical COVID-19 disease.
This was 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. A single arm, non-randomized, open-label phase was added to the protocol after completion of enrollment in the randomized phase of the study. The study had three phases: Screening Period, Treatment Period, and Follow-Up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
484
Placebo
Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
St. Jude Medical Center
Fullerton, California, United States
All-cause Mortality at Day 28
Incidence of mortality at day 28
Time frame: Mortality at day 28 (Visit 2, start of treatment = day 0)
All-cause Mortality at Day 14
Day 0 refers to the data of randomization/first treatment.
Time frame: Mortality at day 14 (initiation of treatment = day 0)
Proportion of Patients Achieving a Category of 6 or Higher on the Ordinal Scale at Days 14 and 28 (on a 7 Point Ordinal Scale).
Evaluation of the clinical status of participants at Day 28 was assessed with a 7-level ordinal scale (OS) (with higher score indicating better outcome). The OS of patient health status ranged 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. The study enrolled hospitalized patients with an OS Score of 2, 3, or 4 at baseline. The OS score of 6 refers to a participant who is not hospitalized with limitation on activities and 7 refers to not hospitalized with no limitations on activities.
Time frame: Change from baseline to days 14 and 28
Change in Clinical Status of Subjects at Day 28 (on a 7 Point Ordinal Scale)
Evaluation of the clinical status of participants at Day 28 was assessed with a 7-level ordinal scale (OS) (with higher score indicating better outcome). The OS of patient health status ranged 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. The study enrolled hospitalized patients with an OS Score of 2, 3, or 4 at baseline. Baseline is last available value before treatment. Change from baseline is based on patients with paired values. The p value is from rank ANCOVA model adjusted for stratification factor and age using imputed data. All results and change from baseline are based on the result of multiple imputation.
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UCLA
Los Angeles, California, United States
James A. Haley Veterans' Hospital
Tampa, Florida, United States
Center for Advanced Research & Education (CARE)
Gainesville, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
St. Barnabas
Livingston, New Jersey, United States
Atlantic Health System Hospital
Morristown, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
New York Community Hospital of Brooklyn
Brooklyn, New York, United States
...and 8 more locations
Time frame: Change from start of treatment (baseline) to day 28
Length of Hospital Stay
Length of Hospital Stay measured in days
Time frame: Timeframe is from screening visit to end of treatment (visit 5)