Clinical trial NCT04941105: Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19
Official title: Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19: the Randomized, Double-blind, Phase III IMPACT-SIRIO 5 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sars-CoV-2 Infection
Keywords: COVID-19
SARS-CoV-2 Pneumonia
PCSK9 inhibitor
Lead sponsor: Collegium Medicum w Bydgoszczy
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Death from any cause or need for intubation
timeFrame: during hospitalization, up to 30 days
Secondary outcomes:
measure: Change in serum interleukin-6 concentration from day 0 to day 7 and day 30
timeFrame: 7 and 30 days from randomization
measure: Death from any cause
timeFrame: during hospitalization, up to 30 days
measure: Need for intubation
timeFrame: during hospitalization, up to 30 days
measure: Duration of oxygen therapy
timeFrame: during hospitalization, up to 30 days
measure: Duration of hospital stay
timeFrame: during hospitalization, up to 30 days
measure: Days of intubation
timeFrame: during hospitalization, up to 30 days
measure: Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)
timeFrame: during hospitalization, up to 30 days
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Antoni Jurasz University Hospital No. 1
Study officials:
affiliation: Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
name: Jacek Kubica, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
name: Eliano Navarese, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: