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Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19 (IMPACT-SIRIO 5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04941105
Recruitment Status : Completed
First Posted : June 28, 2021
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Jacek Kubica, Collegium Medicum w Bydgoszczy

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sars-CoV-2 Infection Drug: Evolocumab Drug: Saline solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : May 17, 2022
Actual Study Completion Date : May 17, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: PCSK9 inhibitor (evolocumab)
140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations
 Drug: Evolocumab
A single subcutaneous administration of 140 mg evolocumab
Placebo Comparator: Usual Care
1 ml of 0,9% saline solution as a single subcutaneous injection. Patients will be treated in accordance to the latest recommendations on caring for patients infected with SARS-CoV-2.
 Drug: Saline solution
A single subcutaneous injection of 1ml of 0,9% saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Death from any cause or need for intubation [ Time Frame: during hospitalization, up to 30 days ]
    Indication for intubation determined individually for each patient and clinical status


Secondary Outcome Measures :
  1. Change in serum interleukin-6 concentration from day 0 to day 7 and day 30 [ Time Frame: 7 and 30 days from randomization ]
  2. Death from any cause [ Time Frame: during hospitalization, up to 30 days ]
    Death from any cause during hospitalization.

  3. Need for intubation [ Time Frame: during hospitalization, up to 30 days ]
    Indication for intubation determined individually for each patient and clinical status

  4. Duration of oxygen therapy [ Time Frame: during hospitalization, up to 30 days ]
    Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)

  5. Duration of hospital stay [ Time Frame: during hospitalization, up to 30 days ]
    Defined as the number of days that pass between the day of hospital admission and discharge or death.

  6. Days of intubation [ Time Frame: during hospitalization, up to 30 days ]
    Defined as the number of days between intubation and extubation

  7. Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC) [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04941105


Locations
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Poland
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland
Sponsors and Collaborators
Collegium Medicum w Bydgoszczy
Investigators
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Principal Investigator: Jacek Kubica, MD, PhD Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
Principal Investigator: Eliano Navarese, Md, PhD Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
More Information
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Responsible Party: Jacek Kubica, Head of Department of Cardiology and Internal Medicine, Collegium Medicum w Bydgoszczy
ClinicalTrials.gov Identifier: NCT04941105    
Other Study ID Numbers: IMPACT-SIRIO 5
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacek Kubica, Collegium Medicum w Bydgoszczy:
COVID-19
SARS-CoV-2 Pneumonia
PCSK9 inhibitor
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Evolocumab
PCSK9 Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Lipid Regulating Agents