Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT04380402
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2020-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atorvastatin as Adjunctive Therapy in COVID-19
Sponsor:
Mount Auburn Hospital
Organization:
Study Overview
Official Title:
Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
STATCO19
Brief Summary:
Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.
Detailed Description:
COVID-19 is caused by SARS-CoV-2, a β-coronavirus that binds to the zinc peptidase angiotensin-converting enzyme 2 (ACE2). No drug is licensed to treat COVID-19, but adjunctive pharmacologic interventions have been proposed for their immunomodulatory effects, including statins. About 5% of cases are considered critical, with severe respiratory failure as well as myocarditis, and thromboses, and are associated with high fatality rate. Statins affect endothelial dysfunction and have anti-inflammatory and immunomodulatory effects.
This prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:
1. Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?
2. Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?
This prospective, randomized, open-label trial of atorvastatin as adjunctive treatment of COVID-19 in hospitalized patients aims to study:
1. Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?
2. Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: