Atorvastatin as Adjunctive Therapy in COVID-19

Phase 2

• Conditions: COVID-19
• Interventions: Drug: Atorvastatin

• Registration Number: NCT04380402
• Lead Sponsor: 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?

Study Timeline

• Study First Submitted: 2020-05-01
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-08
• Study Start: 2020-06-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Primary Completion: 2021-12-31
• Study Completion: 2022-05-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Atorvastatin	40 mg

Primary Outcome Measures

Name	Time	Method
Proportion of patients that progress to severe or critical requiring ICU admission and/or emergency salvage therapy, or death	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

Name	Time	Method
Overall score of patients in each arm on Day 7 based on WHO Ordinal Scale for Clinical Improvement	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.
Overall score of patients in each arm on Day 30 based on WHO Ordinal Scale for Clinical Improvement	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.
Proportions of patients in each arm who test negative for SARS-CoV-2 on Day 7	7 days	Proportions of patients in each arm who are tested on Day 7 and have negative PCR

Trial Locations

Locations (1)

Mount Auburn Hospital; 🇺🇸 Cambridge, Massachusetts, United States