drugset / Trial / NCT05077254

COVID Protection After Transplant-Immunosuppression Reduction

NCT05077254 ↗

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

EvaluationDrugModalityDoseRoute
Subject Moderna COVID-19 Vaccine 2023-2024 Vaccine — Intramuscular
Subject Mycophenolate Mofetil Small molecule — —
Subject Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Vaccine — Intramuscular
Subject Tacrolimus Small molecule — —
Subject Mycophenolate Mofetil Small molecule — —
Subject Tacrolimus Small molecule — —