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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Atorvastatin 40 mg tablet
Mount Auburn Hospital
Cambridge, Massachusetts, United States
RECRUITINGProportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death
Proportion of patients in each arm that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death, as described by WHO Ordinal Scale for Clinical Improvement scores 5-8 with higher being worse.
Time frame: 30 days
Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement
Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 7, scores 1-8 with higher being worse.
Time frame: 7 days
Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement
Description of clinical status of patients in each arm based on WHO Ordinal Scale of Clinical Improvement on Day 30, scores 1-8 with higher being worse.
Time frame: 30 days
Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7
Proportions of patients in each arm who are tested on Day 7 and have negative PCR
Time frame: 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.