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Atorvastatin as Adjunctive Therapy in COVID-19 (STATCO19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Mount Auburn Hospital

Study Description
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Brief Summary:
Objective: To assess whether adjunctive therapy of COVID-19 infection with atorvastatin reduces the deterioration in hospitalized patients and improves clinical outcome.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Atorvastatin Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
40 mg
 Drug: Atorvastatin
Atorvastatin 40 mg tablet
Other Name: atorvastatin calcium
No Intervention: Control
Standard care


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lin H Chen, MD 617-499-5026 lchen@mah.harvard.edu
Contact: Dan Bourque, MD 617-499-5026 dbourque@mah.harvard.edu

Locations
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United States, Massachusetts
Mount Auburn Hospital Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Lin Chen, MD    617-499-5026    lchen@hms.harvard.edu   
Contact: Rita Cosgrove    617-499-5774    rcosgro1@mah.harvard.edu   
Sponsors and Collaborators
Mount Auburn Hospital
Investigators
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Principal Investigator: Lin H Chen, MD Mount Auburn Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Mount Auburn Hospital
ClinicalTrials.gov Identifier: NCT04380402    
Other Study ID Numbers: MountAuburn
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors