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| Column | Value |
|---|---|
| Trial registration number | NCT04941105 |
|
Full text link
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2021-06-28 |
|
Recruitment status
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: written informed consent for participation in the study male and female age 18 or more at the time of signing the informed consent sars-cov-2 infection confirmed by real-time reverse transcription polymerase chain reaction (rt-pcr) covid-19 pneumonia with a typical radiological changes pao2/fio2 ratio less than or equal to 300 covid-19 pneumonia in cytokine storm with elevated serum level of interleukin-6 |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
use of fibrates other than fenofibrate or fenofibric acid known active infections or other clinical condition that contraindicate pcsk9 inhibitors known systemic hypersensitivity to pcsk9 inhibitors estimated glomerular filtration rate <30 ml/min/1.73 m2 absolute neutrophil count (anc) less than 2000/mm3 a platelet count less than 50000/mm3 creatine kinase (ck) greater than 3x upper limit of normal (uln) aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 3x upper limit of normal (uln) not expected to survive for more than 48 hours from screening unrelated co-morbidity with life expectancy <3 months. pregnancy 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 patient being treated with other immunomodulators (except for glucocorticoids). patient included in any other interventional trial. |
|
Number of arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Collegium Medicum w Bydgoszczy |
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Inclusion age min
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Poland |
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Type of patients
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
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Severity scale
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
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Total sample size
Last imported at : Dec. 21, 2022, 8 a.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : July 2, 2022, 11:30 p.m. Source : ClinicalTrials.gov |
Death from any cause or need for intubation |
|
Notes
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : June 30, 2021, 2:30 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 487, "treatment_name": "Evolocumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |