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 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