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

COVID19 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392531
• Other study ID #: FJD-COVID19-20-01
• Status: Completed
• Phase: Phase 4
• Start date: April 16, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2022
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19 Infection
• Infections

Intervention

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)
• Standard treatment
Standard of care according to hospital protocol

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario La Coruña	La Coruña	Galicia
Spain	Hospital Quiron La Coruña	La Coruña	Galicia
Spain	Clinica Universitaria de Navarra	Madrid
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Rey Juan Carlos	Mostoles	Madrid
Spain	Hospital Infanta Elena	Valdemoro	Madrid
Spain	Hospital General de Villalba	Villalba	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity Category	efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.	12 days
Secondary	Mortality Rate	efficacy of CsA in combination with standard treatment in reducing mortality	through study completion, an average of 6 weeks
Secondary	Number of Days in hospital	efficacy of CsA in combination with standard treatment in reducing days in hospital	through study completion, an average of 6 weeks
Secondary	Number of days in ICU beds	efficacy of CsA in combination with standard treatment in reducing days in ICU beds	through study completion, an average of 6 weeks
Secondary	Fio2 Needs	efficacy of CsA in combination with standard treatment in reducing FiO2 needs.	through study completion, an average of 6 weeks
Secondary	Adverse events rate	safety and tolerability of cyclosporine vs standard treatment administration	through study completion, an average of 6 weeks
Secondary	Change in CRP	change from baseline in C reactive protein levels	every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Secondary	Change in ferritin	change from baseline in ferritin levels	every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Secondary	Change in LDH	change from baseline in LDH levels	every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)
Secondary	Change in CPK	change from baseline in Creatin phosphokinase levels	every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Secondary	Change in D Dimer	change from baseline in D Dimer levels	every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)
Secondary	Change in IL-6	change from baseline in IL-6 levels	Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Secondary	Change in KL-6	change from baseline in KL-6 levels	Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Secondary	Change in Viral Load	COVID19 Viral load determination	Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Secondary	Change specific antibodies	Specific IgG and IgM determination	Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)