Atorvastatin as Adjunctive Therapy in COVID-19 (STATCO19)
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|ClinicalTrials.gov Identifier: NCT04380402|
Recruitment Status : Unknown
Verified March 2021 by Mount Auburn Hospital.
Recruitment status was: Recruiting
First Posted : May 8, 2020
Last Update Posted : March 19, 2021
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Atorvastatin||Phase 2|
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:
- Will atorvastatin reduce progression to severe or critical COVID-19 disease and death compared to standard care?
- Will atorvastatin lead to improved clinical outcome of COVID-19 disease at 30 days compared to standard care?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19|
|Actual Study Start Date :||June 25, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||May 8, 2022|
Atorvastatin 40 mg tablet
Other Name: atorvastatin calcium
No Intervention: Control
- Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death [ Time Frame: 30 days ]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.
- Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement [ Time Frame: 7 days ]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.
- Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement [ Time Frame: 30 days ]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.
- Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7 [ Time Frame: 7 days ]Proportions of patients in each arm who are tested on Day 7 and have negative PCR
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04380402
|Contact: Lin H Chen, MDemail@example.com|
|Contact: Dan Bourque, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Mount Auburn Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Lin Chen, MD 617-499-5026 email@example.com|
|Contact: Rita Cosgrove 617-499-5774 firstname.lastname@example.org|
|Principal Investigator:||Lin H Chen, MD||Mount Auburn Hospital|
|Responsible Party:||Mount Auburn Hospital|
|Other Study ID Numbers:||
|First Posted:||May 8, 2020 Key Record Dates|
|Last Update Posted:||March 19, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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