The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
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 of care according to hospital protocol
Complejo Hospitalario Universitario La Coruña
A Coruña, Galicia, Spain
Hospital Quiron La Coruña
A Coruña, Galicia, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain
Severity Category
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
Time frame: 12 days
Mortality Rate
efficacy of CsA in combination with standard treatment in reducing mortality
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 6 weeks
Fio2 Needs
efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Time frame: through study completion, an average of 6 weeks
Adverse events rate
safety and tolerability of cyclosporine vs standard treatment administration
Time frame: through study completion, an average of 6 weeks
Change in CRP
change from baseline in C reactive protein levels
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)
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Hospital General de Villalba
Villalba, Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Clinica Universitaria de Navarra
Madrid, Spain
Change in ferritin
change from baseline in ferritin levels
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 in LDH
change from baseline in LDH levels
Time frame: 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
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 in D Dimer
change from baseline in D Dimer levels
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 in IL-6
change from baseline in IL-6 levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)