Skip to main content
OpenTrials
Completed

NCT Number: NCT04941105

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antoni Jurasz University Hospital No. 1

Bydgoszcz, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evolocumab

Drug

A single subcutaneous administration of 140 mg evolocumab

Saline Solution

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Collegium Medicum w Bydgoszczy

Other

Registry information

Official study 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.

Acronym: IMPACT-SIRIO 5

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2021
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.