Clinical trial to assess the efficacy and safety of cyclosporin A treatment associated with standard treatment versus standard treatment only in hospitalized patients with confirmed coronavirus infectio

Phase 1

• Conditions: COVID-19 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001262-11-ES
• Lead Sponsor: Instituto de Investigación Sanitaria Fundación Jiménez Díaz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-13
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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