Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05238402 |
| Other study ID # |
2021-059 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
March 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Antalya Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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).
