Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.
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?
Drug: Atorvastatin
Atorvastatin 40 mg tablet
Other Name: atorvastatin calcium
Inclusion Criteria:
- 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 Criteria:
- 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.
Mount Auburn Hospital
Cambridge, Massachusetts, United States
Investigator: Lin Chen, MD
Contact: 617-499-5026
lchen@hms.harvard.edu
Lin H Chen, MD
617-499-5026
lchen@mah.harvard.edu
Dan Bourque, MD
617-499-5026
dbourque@mah.harvard.edu
Lin H Chen, MD, Principal Investigator
Mount Auburn Hospital