Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status and phase: Completed; Phase 4

Conditions: COVID19 Infection

Treatments: Drug: Standard treatment; Drug: Cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT04392531

FJD-COVID19-20-01

Details and patient eligibility

About

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

Enrollment: 111 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Group A (control)

Active Comparator group

Description:

The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.

Treatment:

Drug: Standard treatment

Group B (experimental)

Experimental group

Description:

The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.

Treatment:

Drug: Cyclosporine