drugset / Trial / NCT04701528

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

NCT04701528

RandomizedParallel-groupOpen-labelTreatment

Summary

An open-label, 56 day, single-center, exploratory, proof-of-concept study of the anti-viral effect of voclosporin (VCS) with an extended safety follow-up, up to 1 year. Study population are adult KTRs with positive SARS-CoV-2 infection with mild to moderate symptoms. At study entry, subjects are on standard therapy of dual immunosuppressive treatment of prednisone and tacrolimus (TAC), following randomization, 10 out of 20 subjects will remain on this therapy for the duration of the study, while the other 10 subjects will switch to VCS.

Timeline

Start
2020-11-15
Primary completion
2022-03-25
Completion
2022-10-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule
Subject Voclosporin Other / unclassified 47.4 mg