A Phase 2 interventional study of Atorvastatin in COVID-19, sponsored by Mount Auburn Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Mount Auburn Hospital · Phase 2, Interventional, and Treatment
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:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Mount Auburn Hospital as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 mg
Drug: Atorvastatin
Standard care
Atorvastatin 40 mg tablet
Also known as: atorvastatin calcium
Proportion 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
Plan to share: No
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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