Atorvastatin as Adjunctive Therapy in COVID-19

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

Sponsors

Lead Sponsor: Mount Auburn Hospital

Source Mount Auburn Hospital
Brief Summary

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

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?

Overall Status Recruiting
Start Date 2020-06-25
Completion Date 2022-05-08
Primary Completion Date 2021-12-31
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death 30 days
Secondary Outcome
Measure Time Frame
Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement 7 days
Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement 30 days
Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7 7 days
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: Atorvastatin

Description: Atorvastatin 40 mg tablet

Arm Group Label: Treatment

Other Name: atorvastatin calcium

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

85 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Lin H Chen, MD Principal Investigator Mount Auburn Hospital
Overall Contact

Last Name: Lin H Chen, MD

Phone: 617-499-5026

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Mount Auburn Hospital Lin Chen, MD 617-499-5026 [email protected]
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Treatment

Type: Experimental

Description: 40 mg

Label: Control

Type: No Intervention

Description: Standard care

Acronym STATCO19
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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