Atorvastatin as Adjunctive Therapy in COVID-19 (STATCO19)
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|ClinicalTrials.gov Identifier: NCT04380402|
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : March 19, 2021
|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
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, MDfirstname.lastname@example.org|
|Contact: Dan Bourque, MDemail@example.com|
|Principal Investigator:||Lin H Chen, MD||Mount Auburn Hospital|