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NCT04517396 · ClinicalTrials.gov registry record · Phase 2
FEnofibRate as a Metabolic INtervention for COVID-19
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 701
- Enrollment target
NCT04517396: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT04517396 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 701 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04517396, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 701 participants
- Enrollment target
Study Summary
The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with abnormal lipid and carbohydrate metabolism are risk factors for death in COVID-19. Recent studies suggest that COVID-19 progression is dependent on metabolic mechanisms. Moreover, gene expression analyses in cultured human bronchial cells infected with SARS-CoV-2 and lung tissue from patients with COVID-19, indicated a marked shift in cellular metabolism, with excessive intracellular lipid generation. In this cell culture system, fenofibrate (a widely available low-cost generic drug approved by the FDA and multiple other regulatory agencies around the world to treat dyslipemias) at concentrations that can be achieved clinically, markedly inhibited SARS-CoV-2 viral replication. Fenofibrate also has immunomodulatory effects that may be beneficial in the setting of COVID-19. The aim of this trial is to assess the clinical impact of fenofibrate (145 mg/d of Tricor or dose-equivalent preparations for 10 days, with dose adjustment in chronic kidney disease (\[CKD\]) to improve clinical outcomes in patients with COVID-19.
Interventions
- OTHER Placebo
- OTHER Usual care
- OTHER Fenofibrate/fenofibric acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04517396
The ClinicalTrials.gov registry entry for NCT04517396 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 701 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04517396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04517396 about?
NCT04517396 is a clinical study titled "FEnofibRate as a Metabolic INtervention for COVID-19". The severe acute respiratory syndrome coronavirus 2 (SARS-CoC-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Aging, obesity, diabetes, hypertension and other risk factors associated with ...
What is the current status of trial NCT04517396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 701 participants. The study started on 2020-08-18. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04517396?
The interventions under investigation include: Placebo (OTHER), Usual care (OTHER), Fenofibrate/fenofibric acid (OTHER).
Who is sponsoring clinical trial NCT04517396?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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