Official Title
Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection
Brief Summary

The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.

Completed
COVID19 Infection

Drug: Cyclosporine

In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure)

Drug: Standard treatment

Standard of care according to hospital protocol

Eligibility Criteria

Inclusion Criteria:

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 and with entry 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.

Exclusion criteria

1. Known allergy or hypersensitivity to any of the medications included in the treatment
arms or to any of their components.

2. Contraindication for the use of any of the medications included (*)

- CsA: IR EST 4.5 (FG <30 ml / min according to the Cockcroft-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 cockcroft-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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
Spain
Locations

Complejo Hospitalario Universitario La Coruña
La Coruña, Galicia, Spain

Hospital Quiron La Coruña
La Coruña, Galicia, Spain

Hospital Rey Juan Carlos
Mostoles, Madrid, Spain

Hospital Infanta Elena
Valdemoro, Madrid, Spain

Hospital General de Villalba
Villalba, Madrid, Spain

Fundacion Jimenez Diaz
Madrid, Spain

Clinica Universitaria de Navarra
Madrid, Spain

Olga Sanchez Pernaute, MD, PhD, Principal Investigator
FUNDACION JIMENEZ DIAZ

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
NCT Number
MeSH Terms
Infections
COVID-19
Cyclosporine
Cyclosporins