Recruiting
Phase 2

Atorvastatin

Sponsor:

Mount Auburn Hospital

Code:

NCT04380402

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin

Study Details

Brief summary:

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

Conditions

COVID-19

Study ID

NCT04380402

Start date

Jun 25, 2020

Status verified date

Mar, 2021

Completion date

May 8, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

40 mg

no intervention: Control

Standard care

Interventions

Atorvastatin

Atorvastatin 40 mg tablet

Primary outcome measure

  • Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Lin H Chen, MD

617-499-5026lchen@mah.harvard.edu

Dan Bourque, MD

617-499-5026dbourque@mah.harvard.edu

Locations

Mount Auburn Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Lin Chen, MD

617-499-5026lchen@hms.harvard.edu

Rita Cosgrove

617-499-5774rcosgro1@mah.harvard.edu

More Information

Sponsor

Mount Auburn Hospital

Last update posted

Mar 19, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Auburn Hospital on 2021-03-19.