The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Intravenous infusion 120 mg/kg
Standard medical treatment per local policies or guidelines
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario Valle de Hebrón
Barcelona, Spain
Percentage of Subjects Dying or Requiring ICU Admission
Time frame: Up to Day 15
Percentage of Subjects Who are Dependent on Invasive Mechanical Ventilation
Time frame: Day 15
Change from Baseline in National Early Warning Score (NEWS)
Time frame: Day 1 through Day 29
Time to Clinical Response as Assessed by: NEWS ≤ 2 Maintained for 24 hours
Time frame: Day 1 through Day 29
Time to Hospital Discharge
Time frame: Day 1 through Day 29
Duration of ICU Stay
Time frame: Up to Day 29
Duration of Any Oxygen Use
Time frame: Day 1 through Day 29
Duration of Mechanical Ventilation
Time frame: Up to Day 29
Mean Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Absolute Value Change from Baseline in Ordinal Scale
Time frame: Day 1 through Day 29
Percentage of Subjects in Each Severity Category of the 7-Point Ordinal Scale
Time frame: Day 15, Day 29
Time to Sustained Normalization of Temperature
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Hospital Clínico San Carlos
Madrid, Spain
Hospital General Gregorio Marañón
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Príncipe de Asturias
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Time frame: Day 1 through Day 29
Percentage of Subjects who Sustained Normalization of Temperature
Time frame: Day 1 through Day 29
Number of Subjects who Develop Acute Respiratory Distress Syndrome (ARDS)
Time frame: Up to Day 29
Length of Time to Clinical Progression
Time frame: Up to Day 29
Mortality Through Day 29
Time frame: Up to Day 29