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

Primary Purpose

COVID19 Infection

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Cyclosporine
Standard treatment
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Complejo Hospitalario Universitario La Coruña
  • Hospital Quiron La Coruña
  • Hospital Rey Juan Carlos
  • Hospital Infanta Elena
  • Hospital General de Villalba
  • Fundacion Jimenez Diaz
  • Clinica Universitaria de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A (control)

Group B (experimental)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Severity Category
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.

Secondary Outcome Measures

Mortality Rate
efficacy of CsA in combination with standard treatment in reducing mortality
Number of Days in hospital
efficacy of CsA in combination with standard treatment in reducing days in hospital
Number of days in ICU beds
efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Fio2 Needs
efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Adverse events rate
safety and tolerability of cyclosporine vs standard treatment administration
Change in CRP
change from baseline in C reactive protein levels
Change in ferritin
change from baseline in ferritin levels
Change in LDH
change from baseline in LDH levels
Change in CPK
change from baseline in Creatin phosphokinase levels
Change in D Dimer
change from baseline in D Dimer levels
Change in IL-6
change from baseline in IL-6 levels
Change in KL-6
change from baseline in KL-6 levels
Change in Viral Load
COVID19 Viral load determination
Change specific antibodies
Specific IgG and IgM determination

Full Information

First Posted
May 3, 2020
Last Updated
July 13, 2022
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT04392531
Brief Title
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (control)
Arm Type
Active Comparator
Arm Description
The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.
Arm Title
Group B (experimental)
Arm Type
Experimental
Arm Description
The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Standard treatment
Intervention Description
Standard of care according to hospital protocol
Primary Outcome Measure Information:
Title
Severity Category
Description
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Mortality Rate
Description
efficacy of CsA in combination with standard treatment in reducing mortality
Time Frame
through study completion, an average of 6 weeks
Title
Number of Days in hospital
Description
efficacy of CsA in combination with standard treatment in reducing days in hospital
Time Frame
through study completion, an average of 6 weeks
Title
Number of days in ICU beds
Description
efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Time Frame
through study completion, an average of 6 weeks
Title
Fio2 Needs
Description
efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Time Frame
through study completion, an average of 6 weeks
Title
Adverse events rate
Description
safety and tolerability of cyclosporine vs standard treatment administration
Time Frame
through study completion, an average of 6 weeks
Title
Change in CRP
Description
change from baseline in C reactive protein levels
Time Frame
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)
Title
Change in ferritin
Description
change from baseline in ferritin levels
Time Frame
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)
Title
Change in LDH
Description
change from baseline in LDH levels
Time Frame
every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)
Title
Change in CPK
Description
change from baseline in Creatin phosphokinase levels
Time Frame
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)
Title
Change in D Dimer
Description
change from baseline in D Dimer levels
Time Frame
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)
Title
Change in IL-6
Description
change from baseline in IL-6 levels
Time Frame
Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Title
Change in KL-6
Description
change from baseline in KL-6 levels
Time Frame
Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Title
Change in Viral Load
Description
COVID19 Viral load determination
Time Frame
Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)
Title
Change specific antibodies
Description
Specific IgG and IgM determination
Time Frame
Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and men over 18 years old 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) Acceptance and signing of the consent for the study after having received the appropriate information. Exclusion criteria Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components. 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 Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the cockcroft-Gault formula). Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B Pregnancy or lactation Age over 75 years Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed. Refusal to participate 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 At the investigator's discretion, the patient's inability to understand or comply with the study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Sanchez Pernaute, MD, PhD
Organizational Affiliation
FUNDACION JIMENEZ DIAZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario La Coruña
City
La Coruña
State/Province
Galicia
Country
Spain
Facility Name
Hospital Quiron La Coruña
City
La Coruña
State/Province
Galicia
Country
Spain
Facility Name
Hospital Rey Juan Carlos
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28933
Country
Spain
Facility Name
Hospital Infanta Elena
City
Valdemoro
State/Province
Madrid
ZIP/Postal Code
28342
Country
Spain
Facility Name
Hospital General de Villalba
City
Villalba
State/Province
Madrid
ZIP/Postal Code
28400
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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