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The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (control) | Active Comparator | The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol. |
|
| Group B (experimental) | Experimental | The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity Category | efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients. | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | efficacy of CsA in combination with standard treatment in reducing mortality | through study completion, an average of 6 weeks |
| Number of Days in hospital | efficacy of CsA in combination with standard treatment in reducing days in hospital |
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Inclusion Criteria:
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 (*)
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
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| Name | Affiliation | Role |
|---|---|---|
| Olga Sanchez Pernaute, MD, PhD | FUNDACION JIMENEZ DIAZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario La Coruña | A Coruña | Galicia | Spain | |||
| Hospital Quiron La Coruña |
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| Standard treatment | Drug | Standard of care according to hospital protocol |
|
| through study completion, an average of 6 weeks |
| Number of days in ICU beds | efficacy of CsA in combination with standard treatment in reducing days in ICU beds | through study completion, an average of 6 weeks |
| Fio2 Needs | efficacy of CsA in combination with standard treatment in reducing FiO2 needs. | through study completion, an average of 6 weeks |
| Adverse events rate | safety and tolerability of cyclosporine vs standard treatment administration | through study completion, an average of 6 weeks |
| Change in CRP | change from baseline in C reactive protein levels | 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 in ferritin | change from baseline in ferritin levels | 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 in LDH | change from baseline in LDH levels | every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment) |
| Change in CPK | change from baseline in Creatin phosphokinase levels | 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 in D Dimer | change from baseline in D Dimer levels | 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 in IL-6 | change from baseline in IL-6 levels | Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment) |
| Change in KL-6 | change from baseline in KL-6 levels | Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment) |
| Change in Viral Load | COVID19 Viral load determination | Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment) |
| Change specific antibodies | Specific IgG and IgM determination | Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment) |
| A Coruña |
| Galicia |
| Spain |
| Hospital Rey Juan Carlos | Móstoles | Madrid | 28933 | Spain |
| Hospital Infanta Elena | Valdemoro | Madrid | 28342 | Spain |
| Hospital General de Villalba | Villalba | Madrid | 28400 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Clinica Universitaria de Navarra | Madrid | Spain |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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