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

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ClinicalTrials.gov Identifier: NCT04420364
Recruitment Status : Withdrawn (Decline in COVID cases)
First Posted : June 9, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Finnian McCausland, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
COVID Kidney Transplant; Complications Immunosuppression Other: Maintenance or reduction of immunosuppression Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-blind, parallel-group, randomized, active-controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: This is a single-blind trial, in that only the assessor will be blinded to the treatment assignment.
Primary Purpose: Treatment
Official Title: Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease
Actual Study Start Date : May 3, 2021
Actual Primary Completion Date : May 4, 2021
Actual Study Completion Date : May 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance of Immunosuppression
Maintenance of immunosuppression (defined as no change to pre-admission immunosuppression, or reduction in anti-metabolite by up to 50% (to a minimum of MMF 500 mg per day or azathioprine 50 mg per day)
Other: Maintenance or reduction of immunosuppression
Maintenance versus reduction of immunosuppression

Active Comparator: Reduction of Immunosuppression
Reduction of immunosuppression (defined as anti-metabolite withdrawal plus reduction of tacrolimus or cyclosporin, to a minimum target trough concentration of 3 ng/mL for tacrolimus and 50 ng/mL for cyclosporin).
Other: Maintenance or reduction of immunosuppression
Maintenance versus reduction of immunosuppression




Primary Outcome Measures :
  1. Change in IL-6 concentration from baseline to day 7 [ Time Frame: baseline to day 7 ]

Secondary Outcome Measures :
  1. Change in IL-6 concentration from baseline to day 28 [ Time Frame: Baseline to day 28 ]
  2. Change in T cell response to SARS-CoV-2 [ Time Frame: Baseline to day 7 and day 28 ]
  3. Change in titer of serum anti-SARS-CoV-2 antibodies [ Time Frame: Baseline to day 7 and day 28 ]
  4. Change in COVID-19 disease severity score (range 1 to 8; higher worse) [ Time Frame: Through day 28 ]
  5. Proportion of patients needing non-invasive ventilation or intubation [ Time Frame: Through day 28 ]
  6. Proportion of patients developing ANC < 500 cells per microliter [ Time Frame: Through day 28 ]
  7. Proportion of patients developing lymphopenia < 400 cells per microliter [ Time Frame: Through day 28 ]
  8. Length of hospital stay [ Time Frame: Through day 28 ]
  9. Proportion of patients developing biopsy-proven acute rejection [ Time Frame: Through day 28 ]
  10. In-hospital and 28-day mortality [ Time Frame: Through day 28 ]
  11. Adverse and serious adverse events [ Time Frame: Through day 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420364


Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jamil Azzi, MD, PhD Birgham and Women's Hospital
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Responsible Party: Finnian McCausland, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04420364    
Other Study ID Numbers: 2020P001516
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases