Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease

COVID Clinical Trial

Official title:

Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04420364
• Other study ID #: 2020P001516
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: May 3, 2021
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• Immunosuppression
• Kidney Transplant; Complications

Intervention

Other:
• Maintenance or reduction of immunosuppression
Maintenance versus reduction of immunosuppression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IL-6 concentration from baseline to day 7		baseline to day 7
Secondary	Change in IL-6 concentration from baseline to day 28		Baseline to day 28
Secondary	Change in T cell response to SARS-CoV-2		Baseline to day 7 and day 28
Secondary	Change in titer of serum anti-SARS-CoV-2 antibodies		Baseline to day 7 and day 28
Secondary	Change in COVID-19 disease severity score (range 1 to 8; higher worse)		Through day 28
Secondary	Proportion of patients needing non-invasive ventilation or intubation		Through day 28
Secondary	Proportion of patients developing ANC < 500 cells per microliter		Through day 28
Secondary	Proportion of patients developing lymphopenia < 400 cells per microliter		Through day 28
Secondary	Length of hospital stay		Through day 28
Secondary	Proportion of patients developing biopsy-proven acute rejection		Through day 28
Secondary	In-hospital and 28-day mortality		Through day 28
Secondary	Adverse and serious adverse events		Through day 28