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

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz7 sites in 1 country111 target enrollmentApril 16, 2020

ConditionsCOVID19 Infection

InterventionsStandard treatment Cyclosporine

DrugsCyclosporine Standard treatment

Overview

Phase: Phase 4
Intervention: Standard treatment
Conditions: COVID19 Infection
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Enrollment: 111
Locations: 7
Primary Endpoint: Severity Category
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 16, 2020

End Date

March 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

Not provided

Arms & Interventions

Group A (control)

The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.

Intervention: Standard treatment

Group B (experimental)

The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.

Intervention: Cyclosporine

Outcomes

Primary Outcomes

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

Mortality Rate(through study completion, an average of 6 weeks)
Number of Days in hospital(through study completion, an average of 6 weeks)
Number of days in ICU beds(through study completion, an average of 6 weeks)
Change in CPK(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))
Fio2 Needs(through study completion, an average of 6 weeks)
Adverse events rate(through study completion, an average of 6 weeks)
Change in CRP(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(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(every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment))
Change in D Dimer(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(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(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(Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment))
Change specific antibodies(Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment))