Randomized, controlled, blinded clinical trial for the evaluator, to evaluate the efficacy and safety of treatment with cyclosporine A (CsA) associated with standard treatment versus standard treatment only in hospitalized patients with confirmed infection by COVID-19 - FJD-COVID19-20-01

Instituto de Investigación Sanitaria Fundación Jiménez Díaz0 个研究点目标入组 120 人开始时间: 2020年4月13日最近更新: 2022年4月25日

适应症

试验速览

暂无简介。

•Patients must meet all of the following criteria to be included in the study:
•1. Women and men over 18 years old
•2. Clinical diagnosis of COVID19 infection to be subsequently confirmed by PCR or specific IgM isotype Ac (depending on the availability of diagnosis at the time of recruitment) and with admission criteria according to the protocol of action (see Annex 2 )
•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 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Patients who meet any of the following criteria may not be selected to participate in this study:
•1. Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
•2. Contraindication to the use of any of the medications included
•CsA: IR EST 4.5 (FG <30 ml / min according to the Cockroft-Gault formula)
•Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis.
•Lopinavir / ritonavir: severe liver failure
•Remdesivir, darunovir-ritonavir
•Doxycycline, Azithromycin
•3. Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the Cockroft-Gault formula).
•4. Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
•5. Pregnancy or lactation
•6. Age over 75 years
•7. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
•8. Refusal to participate
•9. Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions.
•10. At the investigator's discretion, the patient's inability to understand or comply with the study procedures

发起方

Instituto de Investigación Sanitaria Fundación Jiménez Díaz