Atorvastatin as Adjunctive Therapy in COVID-19

NCT ID: NCT04380402

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2022-05-08

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?

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

40 mg

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Atorvastatin 40 mg tablet

Control

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Atorvastatin

Atorvastatin 40 mg tablet

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Auburn Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin H Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Auburn Hospital

Locations

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lin H Chen, MD

Role: CONTACT

lchen@mah.harvard.edu

617-499-5026

Dan Bourque, MD

Role: CONTACT

dbourque@mah.harvard.edu

617-499-5026

Facility Contacts

Lin Chen, MD

Role: primary

lchen@hms.harvard.edu

617-499-5026

Rita Cosgrove

Role: backup

rcosgro1@mah.harvard.edu

617-499-5774

References

Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

Reference Type: BACKGROUND

PMID: 31986257 (View on PubMed)

Parihar SP, Guler R, Brombacher F. Statins: a viable candidate for host-directed therapy against infectious diseases. Nat Rev Immunol. 2019 Feb;19(2):104-117. doi: 10.1038/s41577-018-0094-3.

Reference Type: BACKGROUND

PMID: 30487528 (View on PubMed)

Vandermeer ML, Thomas AR, Kamimoto L, Reingold A, Gershman K, Meek J, Farley MM, Ryan P, Lynfield R, Baumbach J, Schaffner W, Bennett N, Zansky S. Association between use of statins and mortality among patients hospitalized with laboratory-confirmed influenza virus infections: a multistate study. J Infect Dis. 2012 Jan 1;205(1):13-9. doi: 10.1093/infdis/jir695. Epub 2011 Dec 13.

Reference Type: BACKGROUND

PMID: 22170954 (View on PubMed)

Madjid M, Safavi-Naeini P, Solomon SD, Vardeny O. Potential Effects of Coronaviruses on the Cardiovascular System: A Review. JAMA Cardiol. 2020 Jul 1;5(7):831-840. doi: 10.1001/jamacardio.2020.1286.

Reference Type: BACKGROUND

PMID: 32219363 (View on PubMed)

Fedson DS, Opal SM, Rordam OM. Hiding in Plain Sight: an Approach to Treating Patients with Severe COVID-19 Infection. mBio. 2020 Mar 20;11(2):e00398-20. doi: 10.1128/mBio.00398-20.

Reference Type: BACKGROUND

PMID: 32198163 (View on PubMed)

Related Links

https://clinicaltrials.gov/ct2/show/results/NCT02056340?view=results

Statin therapy in acute influenza

Other Identifiers

MountAuburn

Identifier Type: -

Identifier Source: org_study_id