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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392531
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID19 Infection Drug: Cyclosporine Drug: Standard treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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)




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



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

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


Contacts
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Contact: Olga Sanchez Pernaute, MD, PhD 0034915504800 ext 3218 osanchez@fjd.es
Contact: Lucia Llanos Jimenez, MD, PhD 0034915504800 ext 3214 lucia.llanos@fjd.es

Locations
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Spain
Complejo Hospitalario Universitario La Coruña Recruiting
La Coruña, Galicia, Spain
Principal Investigator: FRANCISCO J BLANCO GARCIA, MD, PhD         
Hospital Quiron La Coruña Recruiting
La Coruña, Galicia, Spain
Principal Investigator: HECTOR MEJIDE, MD, PhD         
Hospital Rey Juan Carlos Recruiting
Mostoles, Madrid, Spain, 28933
Contact: MIREIA ARCAS TOMEO, BSc       mireia.arcas@fjd.es   
Principal Investigator: IGNACIO ROBLES BARRENA, MD, PhD         
Sub-Investigator: CELIA ZAMARRO GARCIA, MD, PhD         
Hospital Infanta Elena Recruiting
Valdemoro, Madrid, Spain, 28342
Contact: MIREIA ARCAS TOMEO, BSc       mireia.arcas@fjd.es   
Principal Investigator: FRANCISCO JAVIER RUIZ HORNILLOS, MD, PhD         
Sub-Investigator: ANGEL JIMENEZ RODRIGUEZ, MD, PhD         
Sub-Investigator: MARCO ANTONIO CASTILLO, MD, PhD         
Hospital General de Villalba Recruiting
Villalba, Madrid, Spain, 28400
Contact: MIREIA ARCAS TOMEO, BSc       mireia.arcas@fjd.es   
Principal Investigator: M JESUS RODRIGUEZ NIETO, MD, PhD         
Sub-Investigator: GLORIA PINDAO QUESADA, MD, PhD         
Sub-Investigator: PATRICIA MILAGROS LAZO MENESES, MD, PhD         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: MIREIA ARCAS TOMEO, BSc    0034915504800 ext 3214    mireia.arcas@fjd.es   
Principal Investigator: Olga Sanchez Pernaute, MD, PhD         
Sub-Investigator: Beatriz Alvarez Alvarez, MD, PhD         
Sub-Investigator: Carolina Maria Gotera Rivera, MD, PhD         
Sub-Investigator: German Peces-Barba Romero, MD, PhD         
Sub-Investigator: Miguel Gorgolas Hernandez, MD, PhD         
Sub-Investigator: Alfonso Cabello Ubeda, MD, PhD         
Sub-Investigator: Cesar Perez Calvo, MD, PhD         
Sub-Investigator: Sara Heili Frades, MD, PhD         
Sub-Investigator: Fredeswinda Romero Bueno, MD, PhD         
Sub-Investigator: Lucia Llanos Jiménez, MD, PhD         
Sub-Investigator: Nerea Carrasco Antón, MD, PhD         
Clinica Universitaria de Navarra Recruiting
Madrid, Spain
Contact: MABEL FIOL PIQUERO         
Principal Investigator: LUIS SEIJO MACEIRAS, MD, PhD         
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
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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: May 19, 2020
Last Verified: May 2020

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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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Infection
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