COVID respiratory infection
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: ROSUVASTATIN
CAS Number: 287714-41-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
Instituto de Investigación Sanitaria Fundación Jiménez Díaz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients older than 45 years. 2. Diagnosed with a positive COVID 19 and having required hospital admission and discharges in the last 3 months, even if they tried to recruit as soon as possible from the time of discharge or just for a follow-up visit when they finished with the medications to the COVID or washout period after cyclosporine. 3. Acceptance and signing of the consent for the study after having received the appropriate information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1080 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1080
Exclusion criteria
Exclusion criteria: 1. Chronic statin treatment at the time of hospitalization. 2. Known allergy or hypersensitivity to statins or any of their components, 3. History of statin intolerance due to increased transaminases, CPK or intolerable myalgias. 4. Severe renal failure: Estimated glomerular filtration <30mL / min / 1.73 m2 calculated by the CKD-EPI formula. 5. Survival <1 year for any known comorbidity 6. Previous liver or heart transplant 7. Patients with myopathy 8. Patients with concomitant treatment with cyclosporine 9. Liver dysfunction (ALT / AST or BT above 3 times the upper limit of normal) 10. Potentially fertile women who are unwilling to use an effective method of contraception. 11. Pregnancy or lactation 12. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Simultaneous participation in observational studies is allowed. 13. At the investigator's discretion, the patient's inability to understand or comply with the study procedures 14. Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if statin treatment has an impact on the poor prognosis (understood as death from any cause, myocardial infarction, ischemic stroke or admission due to heart failure) in the first year in patients discharged from hospital after admission for positive COVID19;Secondary Objective: To determine if statin treatment has an impact on the reduction of admissions for any cause, including hospitalizations for heart failure (these events will be studied in depth in case they could be the consequence of an acute coronary event and be part of the main objective) and pulmonary thromboembolism or deep vein thrombosis, in the first year in patients discharged from hospital after admission for positive COVID19.;Primary end point(s): Death of any cause, myocardial infarction or stroke.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Separate comparisons of events of death from any cause, myocardial infarction, stroke or admission due to heart failure in the group of patients treated with statins compared to the control group, as well as readmission from any cause.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Spain
Contacts
Public ContactCLINICAL RESEARCH UNIT
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH
Outcome results
None listed