drugset / Trial / NCT05077254
COVID Protection After Transplant-Immunosuppression Reduction
Phase 2
Completed
48 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University · collabNYU Langone Health · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
Timeline
- Start
- 2021-12-06
- Primary completion
- 2024-02-28
- Completion
- 2025-02-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BNT162b2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | Elasomeran | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Tacrolimus | Small molecule | — | — |