The IMPACT-SIRIO 5 is a randomized, double-blind, phase III clinical trial aimed to evaluate safety and efficacy of PCSK9 inhibition on clinical outcome in patients during the inflammatory stage of the COVID-19. During the hospitalization participants will be randomized in a 1:1 ratio to either receive PCSK9 inhibitor (evolocumab) or to receive placebo (saline solution). Furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with SARS-CoV-2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
A single subcutaneous administration of 140 mg evolocumab
A single subcutaneous injection of 1ml of 0,9% saline solution
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland
Death from any cause or need for intubation
Indication for intubation determined individually for each patient and clinical status
Time frame: during hospitalization, up to 30 days
Change in serum interleukin-6 concentration from day 0 to day 7 and day 30
Time frame: 7 and 30 days from randomization
Death from any cause
Death from any cause during hospitalization.
Time frame: during hospitalization, up to 30 days
Need for intubation
Indication for intubation determined individually for each patient and clinical status
Time frame: during hospitalization, up to 30 days
Duration of oxygen therapy
Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)
Time frame: during hospitalization, up to 30 days
Duration of hospital stay
Defined as the number of days that pass between the day of hospital admission and discharge or death.
Time frame: during hospitalization, up to 30 days
Days of intubation
Defined as the number of days between intubation and extubation
Time frame: during hospitalization, up to 30 days
Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)
Defined as the number of days between initiation and cessation of Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)
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Time frame: during hospitalization, up to 30 days