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

Sars-CoV-2 Infection Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04941105
• Other study ID #: IMPACT-SIRIO 5
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: April 2023
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Sars-CoV-2 Infection

Intervention

Drug:
• Evolocumab
A single subcutaneous administration of 140 mg evolocumab
• Saline solution
A single subcutaneous injection of 1ml of 0,9% saline solution

Locations

Country	Name	City	State
Poland	Antoni Jurasz University Hospital No. 1	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause or need for intubation	Indication for intubation determined individually for each patient and clinical status	during hospitalization, up to 30 days
Secondary	Change in serum interleukin-6 concentration from day 0 to day 7 and day 30		7 and 30 days from randomization
Secondary	Death from any cause	Death from any cause during hospitalization.	during hospitalization, up to 30 days
Secondary	Need for intubation	Indication for intubation determined individually for each patient and clinical status	during hospitalization, up to 30 days
Secondary	Duration of oxygen therapy	Defined as the number of days of oxygen therapy (including all methods of oxygen therapy)	during hospitalization, up to 30 days
Secondary	Duration of hospital stay	Defined as the number of days that pass between the day of hospital admission and discharge or death.	during hospitalization, up to 30 days
Secondary	Days of intubation	Defined as the number of days between intubation and extubation	during hospitalization, up to 30 days
Secondary	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)	during hospitalization, up to 30 days