Clinical trial to assess the prognostic repercussions of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive.

Phase 1

Active, not recruiting

• Conditions: COVID respiratory infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001319-26-ES
• Lead Sponsor: Instituto de Investigación Sanitaria Fundación Jiménez Díaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-14
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1080

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified