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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392531
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : July 14, 2022
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 16, 2020
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Severity Category [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: through study completion, an average of 6 weeks ]
    efficacy of CsA in combination with standard treatment in reducing FiO2 needs.

  5. Adverse events rate [ Time Frame: through study completion, an average of 6 weeks ]
    safety and tolerability of cyclosporine vs standard treatment administration

  6. Change in CRP [ 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) ]
    change from baseline in C reactive protein levels

  7. Change in ferritin [ 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) ]
    change from baseline in ferritin levels

  8. Change in LDH [ Time Frame: 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 [ 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) ]
    change from baseline in Creatin phosphokinase levels

  10. Change in D Dimer [ 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) ]
    change from baseline in D Dimer levels

  11. Change in IL-6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392531


Locations
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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, 28933
Hospital Infanta Elena
Valdemoro, Madrid, Spain, 28342
Hospital General de Villalba
Villalba, Madrid, Spain, 28400
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Clinica Universitaria de Navarra
Madrid, Spain
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
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Principal Investigator: Olga Sanchez Pernaute, MD, PhD FUNDACION JIMENEZ DIAZ
More Information
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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    Key Record Dates
Last Update Posted: July 14, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors