The Impact of Statin Therapy in the Covid-19 Patients

Sponsor
Antalya Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05238402
Collaborator
(none)
707
1
10
71

Study Details

Study Description

Brief Summary

In the retrospective case series, consecutive COVID-19 patients admitted from June 1 to December 31, 2020, were analyzed. A 1:1 matched cohort was created by propensity score-matched analysis. Demographic data, laboratory findings, comorbidities, treatments, and in-hospital outcomes were collected and compared between COVID-19 patients with and without statin use.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Methods Study population The study is retrospective single-center review of all patients admitted to Antalya Training and Research Center, tested positive for SARS-CoV-2 reverse transcriptase-polymerase chain reaction testing of nasopharyngeal or oropharyngeal specimens from January 1, 2020, to December 31, 2020., and informed consent was waived. The study conformed to the principles of the Declaration of Helsinki and was approved by the ethics committee of Antalya training and research center (2021-059).

Baseline demographic, clinical, and laboratory variables were retrieved from the electronic medical record system. Patients were classified according to the HeartScore high-risk countries risk chart. Patients identified in the very high cardiovascular risk group were included in the analysis. The study population was divided into two groups: patients who received a statin vs. those who did not receive a statin before the hospitalization. The primary outcome was in-hospital mortality during the follow-up period.

Statistical analysis Summary statistics were presented as percentages for categorical variables and medians with interquartile ranges or means with standard deviations for continuous variables. Differences in demographic, clinical characteristics and outpatient medications stratified by statin use were examined using the two-sided independent t-test and chi-squared test, as appropriate.

To minimize the influence of confounding by indication, propensity-score matching was used to balance the clinical characteristics of the two groups. Matching was performed using a 1:1 matching protocol without replacement (greedy-matching algorithm), with a caliper width equal to 0.02 of the standard deviation of the propensity score's logit. The following variables were used for adjustment: age, sex, history of atrial fibrillation, cancer, chronic kidney disease, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease, diabetes mellitus, hypertension, smoking, and corticosteroid treatment. Descriptive analyses were performed for all baseline variables in the overall cohort and the propensity-matched cohort.

To identify potential predictors of mortality, we initially performed a univariate logistic regression in the overall cohort. Covariables with p < 0.20 were selected for entry into the multivariable model, and covariables with p > 0.05 were removed from the final model. Similarly, both univariable and multivariable logistic regression was performed in the propensity-score matched cohort. All analyses were performed with the SAS software version 9.4 (SAS Institute, Inc., Cary, NC, USA).

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
707 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Impact of Statin Therapy in the Covid-19 Patients With Very High Cardiovascular Risk
Actual Study Start Date :
Jun 1, 2020
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
on statins

patients who received a statin

Drug: Statin
Statin on COVID 19 patienst

not on statins

patients who not received a statin

Drug: Statin
Statin on COVID 19 patienst

Outcome Measures

Primary Outcome Measures

  1. Mortality [up to 1 month]

    In-hospital mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • COVID 19 diagnosis

  • Very high cardiovascular risk

Exclusion Criteria:
  • < 40 years old

Contacts and Locations

Locations

Site City State Country Postal Code
1 Deniz Demirci Antalya Turkey

Sponsors and Collaborators

  • Antalya Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deniz Demirci, Principal Investigator, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05238402
Other Study ID Numbers:
  • 2021-059
First Posted:
Feb 14, 2022
Last Update Posted:
Feb 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Deniz Demirci, Principal Investigator, Antalya Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022