NCT04941105

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Collegium Medicum w Bydgoszczy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Sars-CoV-2 Infection

Interventions

Type	Name	Description
DRUG	Evolocumab	A single subcutaneous administration of 140 mg evolocumab
DRUG	Saline solution	A single subcutaneous injection of 1ml of 0,9% saline solution

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2021-06-28
• Last updated: 2023-04-21

Locations

1 site across 1 country: Poland