Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
-An infusion bag of 100 mL of 0.9% saline
Hospital Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Proportion of patients developing treatment failure
• Death
Time frame: At 14 days after randomization
Proportion of patients developing treatment failure
• Need for admission in an intensive care unit (ICU)
Time frame: At 14 days after randomization
Proportion of patients developing treatment failure
• Need for mechanical ventilation
Time frame: At 14 days after randomization
Proportion of patients developing treatment failure
• Decrease in SpO2 \<90% (in ambient air) or PaO2 \<60 mmHg (in ambient air) or PaO2FiO2 \<300 mmHg, associated with radiological impairment
Time frame: At 14 days after randomization
Mortality at day 28
Time frame: At 28 days after randomization
Proportion of patients requiring ICU admission
Time frame: At 28 days after randomization
Proportion of patients requiring rescue-therapy with tocilizumab
Time frame: At 14 days after randomization
Length of hospital stay
Time in days from randomization until the date of hospital discharge.
Time frame: At 28 days after randomization
Proportion of severe adverse events
Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
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Time frame: At 28 days after randomization
Proportion of bacterial, fungal or opportunistic infections
Time frame: At 28 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of C-reactive protein (CRP)
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of ferritin
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of interleukin-6 (IL-6)
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of lactate dehydrogenase (LDH)
Time frame: At 14 days after randomization
Evolution of inflammatory biomarkers related to COVID-19
Change in plasma levels of D-dimer (DD)
Time frame: At 14 days after randomization
Proportion of SARS-CoV-2 clearance.
Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Time frame: At 7 days after randomization