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

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)
• Overall Status: Completed
• CT.gov ID: NCT04392531
• Collaborator: (none)
• Enrollment: 111
• Locations: 7
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site: 15.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID19 Infection	Drug: Cyclosporine; Drug: Standard treatment	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 16, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A (control) The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.	Drug: Standard treatment; Standard of care according to hospital protocol
Experimental: Group B (experimental) The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.	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)

Outcome Measures

Primary Outcome Measures

1. 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

1. Mortality Rate [through study completion, an average of 6 weeks]

   efficacy of CsA in combination with standard treatment in reducing mortality

2. 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

3. 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

4. Fio2 Needs [through study completion, an average of 6 weeks]

   efficacy of CsA in combination with standard treatment in reducing FiO2 needs.

5. Adverse events rate [through study completion, an average of 6 weeks]

   safety and tolerability of cyclosporine vs standard treatment administration

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the cockcroft-Gault formula).

2. Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B

3. Pregnancy or lactation

4. Age over 75 years

5. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.

6. Refusal to participate

7. 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

8. At the investigator's discretion, the patient's inability to understand or comply with the study procedures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Complejo Hospitalario Universitario La Coruña	La Coruña	Galicia	Spain
2	Hospital Quiron La Coruña	La Coruña	Galicia	Spain
3	Hospital Rey Juan Carlos	Mostoles	Madrid	Spain	28933
4	Hospital Infanta Elena	Valdemoro	Madrid	Spain	28342
5	Hospital General de Villalba	Villalba	Madrid	Spain	28400
6	Fundacion Jimenez Diaz	Madrid		Spain	28040
7	Clinica Universitaria de Navarra	Madrid		Spain

Sponsors and Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• ClinicalTrials.gov Identifier: NCT04392531
• Other Study ID Numbers: FJD-COVID19-20-01
• First Posted: May 19, 2020
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; COVID-19; Cyclosporine; Cyclosporins

Study Results

No Results Posted as of Jul 14, 2022