This will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age \>18 years old) with functioning renal transplants admitted to hospital with confirmed COVID-19 disease.
The optimal management of immunosuppression in renal transplant patients with COVID-19 disease is unclear. On one hand, many centers advocate reduction of immunosuppression in infected patients, with the rationale that such an approach will unleash the anti-viral T-cell response. However, on the other hand, some centers advocate there may be rationale to maintain baseline immunosuppression in order to mitigate against development of an uncontrolled over-activation of the immune response. The investigators propose to address this knowledge gap by performing a randomized clinical trial that will test formal comparisons of maintenance versus reduction in immunosuppression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Maintenance versus reduction of immunosuppression
Change in IL-6 concentration from baseline to day 7
Time frame: baseline to day 7
Change in IL-6 concentration from baseline to day 28
Time frame: Baseline to day 28
Change in T cell response to SARS-CoV-2
Time frame: Baseline to day 7 and day 28
Change in titer of serum anti-SARS-CoV-2 antibodies
Time frame: Baseline to day 7 and day 28
Change in COVID-19 disease severity score (range 1 to 8; higher worse)
Time frame: Through day 28
Proportion of patients needing non-invasive ventilation or intubation
Time frame: Through day 28
Proportion of patients developing ANC < 500 cells per microliter
Time frame: Through day 28
Proportion of patients developing lymphopenia < 400 cells per microliter
Time frame: Through day 28
Length of hospital stay
Time frame: Through day 28
Proportion of patients developing biopsy-proven acute rejection
Time frame: Through day 28
In-hospital and 28-day mortality
Time frame: Through day 28
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Adverse and serious adverse events
Time frame: Through day 28