The purpose of the study is to determine if high dose Intravenous IVIG plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus SMT alone in hospitalized participants with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
IVIG Intravenous infusion
SMT
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Del Mar
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Percentage of Participants Dying or Requiring ICU Admission
Time frame: Up to Day 29
Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation
Time frame: Day 29
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
Length of Time to Clinical Progression
Time frame: Up to Day 29
Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale
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Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Getafe
Getafe, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Time frame: Day 15 and Day 29
Time to Sustained Normalization of Temperature
Time frame: Day 1 through Day 29
Percentage of Participants with Normalization of Fever
Time frame: Day 1 through Day 29
Number of Participants who Develop Acute Respiratory Distress Syndrome (ARDS)
Time frame: Day 29