Sars-CoV-2 Infection
Conditions
Keywords
COVID-19, SARS-CoV-2 Pneumonia, PCSK9 inhibitor
Brief summary
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.
Interventions
DRUGEvolocumab
A single subcutaneous administration of 140 mg evolocumab
DRUGSaline solution
A single subcutaneous injection of 1ml of 0,9% saline solution
Sponsors
Collegium Medicum w Bydgoszczy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent for participation in the study 2. Male and female age 18 or more at the time of signing the informed consent 3. SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) 4. COVID-19 pneumonia with a typical radiological changes 5. PaO2/FIO2 ratio less than or equal to 300 6. COVID-19 Pneumonia in cytokine storm with elevated serum level of interleukin-6
Exclusion criteria
1. Use of fibrates other than fenofibrate or fenofibric acid 2. Known active infections or other clinical condition that contraindicate PCSK9 inhibitors 3. Known systemic hypersensitivity to PCSK9 inhibitors 4. Estimated glomerular filtration rate \<30 ml/min/1.73 m2 5. Absolute neutrophil count (ANC) less than 2000/mm3 6. A platelet count less than 50000/mm3 7. Creatine kinase (CK) greater than 3x upper limit of normal (ULN) 8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x upper limit of normal (ULN) 9. Not expected to survive for more than 48 hours from screening 10. Unrelated co-morbidity with life expectancy \<3 months. 11. Pregnancy 12. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 13. Patient being treated with other immunomodulators (except for glucocorticoids). 14. Patient included in any other interventional trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death from any cause or need for intubation | during hospitalization, up to 30 days | Indication for intubation determined individually for each patient and clinical status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death from any cause | during hospitalization, up to 30 days | Death from any cause during hospitalization. |
| Need for intubation | during hospitalization, up to 30 days | Indication for intubation determined individually for each patient and clinical status |
| Duration of oxygen therapy | during hospitalization, up to 30 days | Defined as the number of days of oxygen therapy (including all methods of oxygen therapy) |
| Change in serum interleukin-6 concentration from day 0 to day 7 and day 30 | 7 and 30 days from randomization | — |
| Days of intubation | during hospitalization, up to 30 days | Defined as the number of days between intubation and extubation |
| Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC) | during hospitalization, up to 30 days | Defined as the number of days between initiation and cessation of Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC) |
| Duration of hospital stay | during hospitalization, up to 30 days | Defined as the number of days that pass between the day of hospital admission and discharge or death. |
Countries
Poland
Outcome results
None listed