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

Phase 4

Completed

• Conditions: COVID19 Infection
• Interventions: Drug: Standard treatment; Drug: Cyclosporine

• Registration Number: NCT04392531
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (control)	Standard treatment	The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.
Group B (experimental)	Cyclosporine	The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.

Primary Outcome Measures

Name	Time	Method
Severity Category	12 days	efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.

Secondary Outcome Measures

Name	Time	Method
Mortality Rate	through study completion, an average of 6 weeks	efficacy of CsA in combination with standard treatment in reducing mortality
Number of Days in hospital	through study completion, an average of 6 weeks	efficacy of CsA in combination with standard treatment in reducing days in hospital
Number of days in ICU beds	through study completion, an average of 6 weeks	efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Fio2 Needs	through study completion, an average of 6 weeks	efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Adverse events rate	through study completion, an average of 6 weeks	safety and tolerability of cyclosporine vs standard treatment administration
Change in CRP	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)	change from baseline in C reactive protein levels
Change in ferritin	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)	change from baseline in ferritin levels
Change in LDH	every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)	change from baseline in LDH levels
Change in CPK	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)	change from baseline in Creatin phosphokinase levels
Change in D Dimer	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)	change from baseline in D Dimer levels
Change in IL-6	Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)	change from baseline in IL-6 levels
Change in KL-6	Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)	change from baseline in KL-6 levels
Change in Viral Load	Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)	COVID19 Viral load determination
Change specific antibodies	Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)	Specific IgG and IgM determination

Trial Locations

Locations (7)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Clinica Universitaria de Navarra; 🇪🇸 Madrid, Spain

Hospital General de Villalba; 🇪🇸 Villalba, Madrid, Spain

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