Clinical Trials Directory

Trials / Completed

CompletedNCT04979884

Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital

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
Phase
Phase 3
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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 g/L, ANC ≥0.5x109/L, platelets ≥100x109/L) • * No hyperferritinemia ≥500 μg/L * (Decrease of IL2)

Conditions

Interventions

TypeNameDescription
DRUGcyclosporineDose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days

Timeline

Start date
2022-01-03
Primary completion
2022-09-09
Completion
2022-12-09
First posted
2021-07-28
Last updated
2025-05-14

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04979884. Inclusion in this directory is not an endorsement.