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

NCT04941105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Evolocumab

A single subcutaneous administration of 140 mg evolocumab

DRUG

Saline solution

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

Sponsors & Collaborators

  • Collegium Medicum w Bydgoszczy

    lead OTHER

Principal Investigators

  • Jacek Kubica, MD, PhD · Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

  • Eliano Navarese, Md, PhD · Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-05-17
Completion
2022-05-17

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941105 on ClinicalTrials.gov