COVID-19NCT05238402
The Impact of Statin Therapy in the Covid-19 Patients
An observational study of COVID-19, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Statin
- How many people
- 707 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 31 Mar 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: We conducted a retrospective single-center review of all patients admitted to Antalya Training and Research Center in Antalya Turkey, 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
Who may be able to join
- COVID 19 diagnosis
- Very high cardiovascular risk
Who cannot join
- < 40 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Statin Therapy in the Covid-19 Patients With Very High Cardiovascular Risk
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- Statin
- Keywords
- COVID-19, Coronavirus, High cardiovascular risk, Pandemic, Statin Therapy
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Statin on COVID 19 patienst
| Study group | Role | What they receive |
|---|---|---|
| on statins | patients who received a statin Receives: Drug: Statin | |
| not on statins | patients who not received a statin Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 707 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Deniz Demirci, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238402
- Sponsor's protocol ID
- 2021-059
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Statin Therapy in the Covid-19 Patients With Very High Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT05238402
- Acronym / sponsor ID
- 2021-059
- Conditions
- COVID-19
- Keywords
- COVID-19, Coronavirus, High cardiovascular risk, Pandemic, Statin Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 707 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| on statins | – | Drug: Statinpatients who received a statin |
| not on statins | – | Drug: Statinpatients who not received a statin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We conducted a retrospective single-center review of all patients admitted to Antalya Training and Research Center in Antalya Turkey, 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
Key inclusion criteria (2 listed)
- COVID 19 diagnosis
- Very high cardiovascular risk
Key exclusion criteria (1 listed)
- < 40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinStatin on COVID 19 patienst | Drug | not on statins, on statins |
Primary outcome
Mortality
Time frame: up to 1 month
In-hospital mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.