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

Primary Purpose

Sars-CoV-2 Infection

Status

Completed

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

Evolocumab

Saline solution

About this trial

This is an interventional treatment trial for Sars-CoV-2 Infection focused on measuring COVID-19, SARS-CoV-2 Pneumonia, PCSK9 inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Antoni Jurasz University Hospital No. 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PCSK9 inhibitor (evolocumab)

Usual Care

Arm Description

140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations

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.

Outcomes

Primary Outcome Measures

Death from any cause or need for intubation

Indication for intubation determined individually for each patient and clinical status

Secondary Outcome Measures

Change in serum interleukin-6 concentration from day 0 to day 7 and day 30

Death from any cause

Death from any cause during hospitalization.

Need for intubation

Indication for intubation determined individually for each patient and clinical status

Duration of oxygen therapy

Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)

Duration of hospital stay

Defined as the number of days that pass between the day of hospital admission and discharge or death.

Days of intubation

Defined as the number of days between intubation and extubation

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)

Full Information

NCT ID

NCT04941105

First Posted

June 21, 2021

Last Updated

April 20, 2023

Sponsor

Collegium Medicum w Bydgoszczy

1. Study Identification

Unique Protocol Identification Number

NCT04941105

Brief Title

Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19

Acronym

IMPACT-SIRIO 5

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

May 17, 2022 (Actual)

Study Completion Date

May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Collegium Medicum w Bydgoszczy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sars-CoV-2 Infection

Keywords

COVID-19, SARS-CoV-2 Pneumonia, PCSK9 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCSK9 inhibitor (evolocumab)

Arm Type

Experimental

Arm Description

140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations

Arm Title

Usual Care

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Evolocumab

Intervention Description

A single subcutaneous administration of 140 mg evolocumab

Intervention Type

Drug

Intervention Name(s)

Saline solution

Intervention Description

A single subcutaneous injection of 1ml of 0,9% saline solution

Primary Outcome Measure Information:

Title

Death from any cause or need for intubation

Description

Indication for intubation determined individually for each patient and clinical status

Time Frame

during hospitalization, up to 30 days

Secondary Outcome Measure Information:

Title

Change in serum interleukin-6 concentration from day 0 to day 7 and day 30

Time Frame

7 and 30 days from randomization

Title

Death from any cause

Description

Death from any cause during hospitalization.

Time Frame

during hospitalization, up to 30 days

Title

Need for intubation

Description

Indication for intubation determined individually for each patient and clinical status

Time Frame

during hospitalization, up to 30 days

Title

Duration of oxygen therapy

Description

Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)

Time Frame

during hospitalization, up to 30 days

Title

Duration of hospital stay

Description

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

Title

Days of intubation

Description

Defined as the number of days between intubation and extubation

Time Frame

during hospitalization, up to 30 days

Title

Time with Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)

Description

Defined as the number of days between initiation and cessation of Non-invasive mechanical ventilation (NIV) or High-flow nasal cannula (HFNC)

Time Frame

during hospitalization, up to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacek Kubica, MD, PhD

Organizational Affiliation

Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eliano Navarese, Md, PhD

Organizational Affiliation

Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Antoni Jurasz University Hospital No. 1

City

Bydgoszcz

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19

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