Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-25 @ 6:51 PM
Study NCT ID:
NCT05080192
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 Survivors - Effect of Fenofibrate
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
Cardiovascular, Pulmonary, and Integrative Functional Phenotypes in COVID-19 - Effect of Fenofibrate
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The trial is testing a short intervention (10 days of fenofibrate therapy) on 30-day outcomes in COVID-19. The overarching goal of this sub-study is to explore the impact of fenofibrate on key longer term phenotypes of vascular, cardiac and pulmonary health, integrated cardiopulmonary function, persistent/chronic symptoms and quality of life.
Detailed Description:
The International multicenter FEnofibRate as a Metabolic INtervention for COVID-19 (FERMIN) trial is being executed. The aim of this trial is to assess the impact of fenofibrate (administered for 10 days) to improve clinical outcomes in patients with COVID-19, assessed at 30 days. However, given the accumulating evidence of chronic / long term sequelae of COVID-19, it is important to assess the long-term impact of this intervention in this patient population. The overarching goal of this substudy is to assess the impact of fenofibrate on key intermediate phenotypes of vascular, cardiac and pulmonary health. We also aim to address the impact of fenofibrate therapy (administered during the acute COVID-19 episode as part of the parent FERMIN trial) on long-term integrated cardiopulmonary function, persistent/chronic symptoms and quality of life. We will accomplish this via enrollment of previous FERMIN participants from the University of Pennsylvania, in an phenotyping study designed to assess vascular, cardiac and pulmonary status several months after the index episode of COVID-19. We will perform these assessments \~6 months after initial randomization, among 40 FERMIN trial participants enrolled at the University of Pennsylvania.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: