Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04979884
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-07-14
Brief Title:
Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Safety and Therapeutic Efficacy of Cyclosporine Plus Standard of Care Treatment on ARDS in COVID -19 Patients at Alexandria University Hospitals in 2021 a Comparative Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study to evaluate the effect of cyclosporine IL2 inhibitor and antiviral verse standard care treatment on decrease ADRS hyper inflammation hypercytokinemia and the mortality rate
Detailed Description:
To test the efficacy of IL-2 inhibitors Cyclosporine compared to the Standard of care according to hospital protocol on COVID-19 patients concerning the clinical outcome cytokines level clinical improvement and PCR of SARS-CoV-2 through the study period
AIM
The slow progression of the disease improving survival among COVID-19 patients and Standard assessment of patient improvement
Standard assessment of patient improvement
PCR-SARS-CoV-2 negative
No fever
No cytopenia Hb 90 gL ANC 05x109L platelets 100x109L
No hyperferritinemia 500 μgL
Decrease of IL2
AIM
The slow progression of the disease improving survival among COVID-19 patients and Standard assessment of patient improvement
Standard assessment of patient improvement
PCR-SARS-CoV-2 negative
No fever
No cytopenia Hb 90 gL ANC 05x109L platelets 100x109L
No hyperferritinemia 500 μgL
Decrease of IL2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None