Title
Clinical Trial to Assess Efficacy of cYclosporine Plus Standard of Care in Hospitalized Patients With COVID19
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
Phase
Phase 4Lead Sponsor
Universidad Autonoma de MadridStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
COVID19 InfectionIntervention/Treatment
Cyclosporine ...Study Participants
111The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
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
The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.
The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.
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
