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

Sponsor
Collegium Medicum w Bydgoszczy
Study ID
NCT04941105
Phase
PHASE3
Status
Completed

Conditions

  • Sars-CoV-2 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Apr 2023
Primary completion
May 17, 2022
Completion
May 17, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PCSK9 inhibitor (evolocumab)
    140 mg of evolocumab as a single subcutaneous injection and standard of care accordance to the latest recommendations
  • Placebo Comparator: Usual Care
    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.

Primary Outcome Measure

Death from any cause or need for intubation [ Time Frame: during hospitalization, up to 30 days ]

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