Clinical trial to assess the efficacy and safety of cyclosporin A treatment associated with standard treatment versus standard treatment only in hospitalized patients with confirmed coronavirus infection

Randomized, controlled, blinded clinical trial for the evaluator, to evaluate the efficacy and safety of treatment with cyclosporine A (CsA) associated with standard treatment versus standard treatment only in hospitalized patients with confirmed infection by COVID-19 - FJD-COVID19-20-01

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001262-11-ES

Enrollment

120

Registered

2020-04-13

Start date

2020-04-09

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infection

Interventions

Pharmaceutical Form: Capsule, soft INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet all of the following criteria to be included in the study: 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 (depending on the availability of diagnosis at the time of recruitment) and with admission 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria may not be selected to participate in this study: 1. Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components. 2. Contraindication to the use of any of the medications included • CsA: IR EST 4.5 (FG <30 ml / min according to the Cockroft-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 Cockroft-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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of the association of CsA with standard treatment in reducing the severity of COVID19-confirmed infection in hospitalized patients.;Secondary Objective: -To assess the efficacy of CsA in combination with standard treatment in reducing mortality, days in hospital, days in ICU beds, and FiO2. - Compare the evolution of BP, plasma creatinine, lymphocyte count, lymphocyte activation markers and CD4 between both groups. - To evaluate the safety of the association of CsA with the standard treatment of hospitalized patients with confirmed infection by COVID19. - To study the possible differences in the modification in the viral load and the seroconversion parameters (IgM and IgG to the virus) throughout the process in both groups. -To assess the incidence of the use of CsA in combination with standard treatment in the reduction of ferritin, LDH and PCR levels from admission, in the CPK and D-dimer peak, in the KL6 peak and in IL6 levels at the same time. throughout evolution. - Evaluate the relationship between CsA doses (mean in mg / kg / day and accumulated) and improvement parameters.;Primary end point(s): Proportion of patients in a non-serious category at 12 days of treatment;Timepoint(s) of evaluation of this end point: At 12 days of treatment	—

Measure

Time frame

Main Objective: To assess the efficacy of the association of CsA with standard treatment in reducing the severity of COVID19-confirmed infection in hospitalized patients.;Secondary Objective: -To assess the efficacy of CsA in combination with standard treatment in reducing mortality, days in hospital, days in ICU beds, and FiO2. - Compare the evolution of BP, plasma creatinine, lymphocyte count, lymphocyte activation markers and CD4 between both groups. - To evaluate the safety of the association of CsA with the standard treatment of hospitalized patients with confirmed infection by COVID19. - To study the possible differences in the modification in the viral load and the seroconversion parameters (IgM and IgG to the virus) throughout the process in both groups. -To assess the incidence of the use of CsA in combination with standard treatment in the reduction of ferritin, LDH and PCR levels from admission, in the CPK and D-dimer peak, in the KL6 peak and in IL6 levels at the same time. throughout evolution. - Evaluate the relationship between CsA doses (mean in mg / kg / day and accumulated) and improvement parameters.;Primary end point(s): Proportion of patients in a non-serious category at 12 days of treatment;Timepoint(s) of evaluation of this end point: At 12 days of treatment

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Secondary

Measure	Time frame
Secondary end point(s): The following comparisons will be made between both groups: - mortality, days of hospitalization, days of intensive care unit beds and FiO2. - evolution of BP, plasma creatinine, lymphocyte count and CD4 - reduction of the levels of ferritin, LDH and PCR from the entrance, in the peak of CPK and D-dimer, in the peak of KL6 and in the levels of IL6 throughout the evolution. - Relationship between dose (mean in mg / kg / day and accumulated) and improvement parameters. - proportion and description of AA - Relationship between plasma levels, efficacy and tolerability.;Timepoint(s) of evaluation of this end point: 7 days after hospital admission	—

Measure

Time frame

Secondary end point(s): The following comparisons will be made between both groups: - mortality, days of hospitalization, days of intensive care unit beds and FiO2. - evolution of BP, plasma creatinine, lymphocyte count and CD4 - reduction of the levels of ferritin, LDH and PCR from the entrance, in the peak of CPK and D-dimer, in the peak of KL6 and in the levels of IL6 throughout the evolution. - Relationship between dose (mean in mg / kg / day and accumulated) and improvement parameters. - proportion and description of AA - Relationship between plasma levels, efficacy and tolerability.;Timepoint(s) of evaluation of this end point: 7 days after hospital admission

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Countries

Spain

Contacts

Public ContactCLINICAL RESEARCH UNIT

FUNDACION JIMENEZ DIAZ HEALTH RESEARCH

mireia.arcas@fjd.es+00349155048003214

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026