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CyclosporineWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2348 Standard treatment Wiki 0.29

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D006973 Hypertension NIH 0.20
D002318 Cardiovascular Diseases NIH 0.15
D007239 Infection NIH 0.04

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0000822 Hypertension HPO 0.20
HP:0001626 Abnormality of the cardiovascular system HPO 0.15

There are 2 clinical trials

Clinical Trials

1 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

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

NCT04392531 COVID19 Infection Drug: Cyclosporine Drug: Standard treatment
MeSH:Infection

Primary Outcomes

Description: efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.

Measure: Severity Category

Time: 12 days

Secondary Outcomes

Description: efficacy of CsA in combination with standard treatment in reducing mortality

Measure: Mortality Rate

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing days in hospital

Measure: Number of Days in hospital

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing days in ICU beds

Measure: Number of days in ICU beds

Time: through study completion, an average of 6 weeks

Description: efficacy of CsA in combination with standard treatment in reducing FiO2 needs.

Measure: Fio2 Needs

Time: through study completion, an average of 6 weeks

Description: safety and tolerability of cyclosporine vs standard treatment administration

Measure: Adverse events rate

Time: through study completion, an average of 6 weeks

Description: change from baseline in C reactive protein levels

Measure: Change in CRP

Time: 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)

Description: change from baseline in ferritin levels

Measure: Change in ferritin

Time: 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)

Description: change from baseline in LDH levels

Measure: Change in LDH

Time: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: change from baseline in Creatin phosphokinase levels

Measure: Change in CPK

Time: 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)

Description: change from baseline in D Dimer levels

Measure: Change in D Dimer

Time: 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)

Description: change from baseline in IL-6 levels

Measure: Change in IL-6

Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: change from baseline in KL-6 levels

Measure: Change in KL-6

Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: COVID19 Viral load determination

Measure: Change in Viral Load

Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

Description: Specific IgG and IgM determination

Measure: Change specific antibodies

Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)

2 Phase I Trial for the Prevention of Cytokine Release Syndrome (CRS) With Cyclosporine in Patients With Moderate COVID-19

Phase 1 safety study to determine the tolerability, clinical effects, and changes in laboratory parameters of short course oral or IV cyclosporine (CSA) administration in patients with COVID-19 disease requiring oxygen supplementation but not requiring ventilator support.

NCT04412785 COVID-19 Drug: Cyclosporine

Primary Outcomes

Description: Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation

Measure: Safety-oxygen, ICU transfer and ventilation

Time: 3 months

Description: Safety will be assessed: By monitoring changes in absolute lymphocyte counts

Measure: Safety-changes in absolute lymphocyte count

Time: 3 months

Description: Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.

Measure: Safety-changes in creatinine clearance

Time: 3 months

Description: Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization

Measure: Safety-secondary bacterial infections

Time: 3 months

Secondary Outcomes

Description: To measure time to SARS-CoV-2 clearance (PCR negativity) at Days 7 and 14 by deep nasal swab

Measure: Laboratory measurements of safety and antiviral efficacy related to COVID-19-SARS-CoV-2 by measuring the clearance of SARS-CoV-2 from respiratory secretions

Time: 3 months

Description: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: D-dimer levels

Measure: Laboratory measurements-D-dimer levels

Time: 3 months

Description: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: ferritin levels

Measure: Laboratory measurements-ferritin

Time: 3 months

Description: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: IL-6 levels

Measure: Laboratory measurements- IL-6

Time: 3 months

No related HPO nodes (Using clinical trials)