drugset / Trial / NCT04701528
Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients
Phase 2
Completed
20 enrolled
Leiden University Medical Center
Aurinia Pharmaceuticals Inc. · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tacrolimus | Small molecule | — | — |
| Subject | Voclosporin | Other / unclassified | 47.4 mg | — |