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.
Other: Maintenance or reduction of immunosuppression
Maintenance versus reduction of immunosuppression
Inclusion Criteria:
- Adults ≥18 years
- COVID positive by RT-PCR or serology
- ≥ 6 months post-transplant
- use of anti-metabolite (mycophenolate or azathioprine) and calcineurin inhibitor
(cyclosporin or tacrolimus)
- informed consent; first admission during study period
- participation within 72 hours of hospitalization
Exclusion Criteria:
- ICU care or need for invasive ventilation or use of pressors at
screening/randomization
- COVID-19 disease severity score more than 5 at screening/randomization
- Known donor specific antibody
- eGFR <20ml/min/1.73m2
- hematocrit <24%
- biopsy proven and treated rejection within last 3 months
- institutionalized individuals (prisoners)
- pregnancy
- participation in another clinical study with an investigational medicinal product
within 30 days or within 5 half-lives of such, whichever is longer, prior to
randomization and during the study
- any other conditions, which, in the opinion of the investigator would make the subject
unsuitable.
Jamil Azzi, MD, PhD, Principal Investigator
Birgham and Women's Hospital