Name (Synonyms) | Correlation | |
---|---|---|
drug3386 | observational Wiki | 0.33 |
drug2730 | Standard treatment Wiki | 0.24 |
Name (Synonyms) | Correlation | |
---|---|---|
D015428 | Myocardial Reperfusion Injury NIH | 0.58 |
D015427 | Reperfusion Injury NIH | 0.58 |
D002318 | Cardiovascular Diseases NIH | 0.22 |
D014947 | Wounds and Injuries NIH | 0.11 |
D007239 | Infection NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.21 |
There are 3 clinical trials
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
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 daysDescription: efficacy of CsA in combination with standard treatment in reducing mortality
Measure: Mortality Rate Time: through study completion, an average of 6 weeksDescription: 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 weeksDescription: 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 weeksDescription: efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Measure: Fio2 Needs Time: through study completion, an average of 6 weeksDescription: safety and tolerability of cyclosporine vs standard treatment administration
Measure: Adverse events rate Time: through study completion, an average of 6 weeksDescription: 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)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.
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 monthsDescription: Safety will be assessed: By monitoring changes in absolute lymphocyte counts
Measure: Safety-changes in absolute lymphocyte count Time: 3 monthsDescription: 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 monthsDescription: Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization
Measure: Safety-secondary bacterial infections Time: 3 monthsDescription: 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 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: D-dimer levels
Measure: Laboratory measurements-D-dimer levels Time: 3 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: ferritin levels
Measure: Laboratory measurements-ferritin Time: 3 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: IL-6 levels
Measure: Laboratory measurements- IL-6 Time: 3 monthsPhase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.
Description: WHO COVID-19 clinical severity scale
Measure: WHO COVID-19 clinical severity scale Time: Through study completion, an average of 1 month.