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Completed

NCT Number: NCT04392531

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

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

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Key information

Conditions

covid19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Complejo Hospitalario Universitario La Coruña, A Coruña, Galicia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine

Drug

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)

standard treatment

Drug

Standard of care according to hospital protocol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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