NCT04407273

Brief Summary

Considering that simvastatin, and probably statins in general, interfere with SARS-cov-2 cellular uptake and some inflammatory pathways activated by the virus, those patients on statin therapy should be less vulnerable to infection and their clinical course and prognosis should be better than that in individuals not on statin therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,159

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 14, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

May 27, 2020

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • SARS-cov-2 scale of severity (9 steps) in Covid-19 infected patients with statin therapy

    Assess the difference in the WHO SARS-cov-2 scale of severity (9 steps) achieved by Covid-19 infected patients, admitted in the hospital, with and without background statin therapy comparable in age and gender distribution

    at the time of admission

Study Arms (2)

with statins

Covid-19 infected patients with statins

Drug: observational

without statins

Covid-19 infected patients without statins

Drug: observational

Interventions

observational study

with statinswithout statins

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a retrospective observational multicentre study based on clinical records review. The following centres will take part in the study: LIPIDCAS Group: * Hospital Universitari Sant Joan * Hospital Universitari Joan XXIII * Hospital Sant Pau i Santa Tecla * Hospital Verge de la Cinta * Pius Hospital de Valls * Hospital del Vendrell Other centres from the LIPID AND ARTERIOSCLEROSIS UNITS NET (XULA) from Catalonia.

You may qualify if:

  • Patients ≥ 18 years old with a PCR or immunological confirmation of Covid-19 infection, admitted in the hospital for at least 24 hours, will be included.

You may not qualify if:

  • Patients \< 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultat de Medicina i Ciències de la Salut de Reus

Reus, Tarragona, 43201, Spain

Location

Related Publications (1)

  • Masana L, Correig E, Rodriguez-Borjabad C, Anoro E, Arroyo JA, Jerico C, Pedragosa A, Miret M, Naf S, Pardo A, Perea V, Perez-Bernalte R, Plana N, Ramirez-Montesinos R, Royuela M, Soler C, Urquizu-Padilla M, Zamora A, Pedro-Botet J. Effect of statin therapy on SARS-CoV-2 infection-related mortality in hospitalized patients. Eur Heart J Cardiovasc Pharmacother. 2022 Feb 16;8(2):157-164. doi: 10.1093/ehjcvp/pvaa128.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Lluís Masana, Dr

    Institut Investigacio Sanitaria Pere Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

May 14, 2020

Primary Completion

August 20, 2020

Study Completion

December 30, 2020

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations