Status:
UNKNOWN
Atorvastatin as Adjunctive Therapy in COVID-19
Lead Sponsor:
Mount Auburn Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 intervent...
Eligibility Criteria
Inclusion
- Patient aged 18-85 years, admitted with suspected COVID-19 disease based on clinical criteria (typical upper respiratory symptoms, e.g. runny nose, sore throat, dry cough, associated with COVID-19 infection).
Exclusion
- already on chronic statin therapy, known hypersensitivity or adverse events to statins, negative nasopharyngeal (NP) swab for SARS-CoV-2, pregnancy and lactation, need for ICU admission, ALT or AST \>2X upper limit of normal; CPK \> 5x upper limit of normal; and creatinine clearance \<50%, chronic treatment with colchicine, cyclosporin, digoxin, fusidic acid, azole antifungals, niacin.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04380402
Start Date
June 25 2020
End Date
May 8 2022
Last Update
March 19 2021
Active Locations (1)
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1
Mount Auburn Hospital
Cambridge, Massachusetts, United States, 02138