Created at Source Raw Value Validated value
Oct. 28, 2021, noon oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Kidney transplant recipients receiving standard of care immunosuppression with tacrolimus; mycophenolate; and steroids; who are deemed to be non-responders or low-responders to conventional 2-dose COVID-19 vaccination; will be randomised to switch from mycophenolate to sirolimus. Participants will initially have mycophenolate ceased; and sirolimus tablets commenced at 2mg daily. The dose of sirolimus will be adjusted weekly to target trough levels of 3-6 ng/mL. Once sirolimus levels are therapeutic; tacrolimus dose will be adjusted to target trough levels of 3-5 ng/mL. Adherence will be monitored through weekly drug level monitoring. Four weeks after randomisation; participants will receive a 3rd COVID-19 mRNA vaccine dose (Pfizer Comirnaty). All participants will receive COVID vaccination during a clinical trial visit to ensure adherence. Participants will continue the altered immunosuppression regimen until measurement of vaccine responses at 4-6 weeks post vaccination. At that stage patients will be able to either continue the intervention immunosuppression or switch back to usual immunosuppression in conjunction with their treating nephrologist.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 2022, "treatment_name": "Bnt162b2+sirolimus", "treatment_type": "Rna based vaccine+immunosuppressants", "pharmacological_treatment": "Vaccine+pharmacological treatment"}, {"arm_notes": "third dose;Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]