NCT04380402

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2022

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

May 1, 2020

Last Update Submit

March 17, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (3)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL

40 mg

Drug: Atorvastatin

Control

NO INTERVENTION

Standard care

Interventions

AtorvastatinDRUG

Atorvastatin 40 mg tablet

Also known as: atorvastatin calcium
Treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 31986257BACKGROUND

  • 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.

    PMID: 30487528BACKGROUND

  • 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.

    PMID: 22170954BACKGROUND

  • 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.

    PMID: 32219363BACKGROUND

  • 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.

    PMID: 32198163BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Lin H Chen, MD

    Mount Auburn Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin H Chen, MD

CONTACT

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

Dan Bourque, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 8, 2020

Study Start

June 25, 2020

Primary Completion

December 31, 2021

Study Completion

May 8, 2022

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)