Atorvastatin as Adjunctive Therapy in COVID-19 (STATCO19)

March 17, 2021 updated by: Mount Auburn Hospital

Prospective Randomized Open-label Trial of Atorvastatin as Adjunctive Treatment of COVID-19

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care
Experimental: Treatment
40 mg
Drug: Atorvastatin
Atorvastatin 40 mg tablet
Other Names:
  • atorvastatin calcium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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.
30 days
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Auburn Hospital

Investigators

  • Principal Investigator: Lin H Chen, MD, Mount Auburn Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

May 8, 2022

Study Registration Dates

First Submitted

May 1, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MountAuburn

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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