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SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study

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ClinicalTrials.gov Identifier: NCT04494776
Recruitment Status : Recruiting
First Posted : July 31, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Hospital do Rim e Hipertensão
Information provided by (Responsible Party):
Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão

Brief Summary:
COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.

Condition or disease
SARS-CoV-2 Infection Kidney Transplant Infection

Detailed Description:
COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions (mechanical ventilation, need for dialysis, need for ICU admission during evolution) and the outcomes of COVID-19 (death and graft loss within 3 months after infection up to 3 months after resolution) in kidney transplant recipients in a national multicenter cohort.Inclusion Criteria:1. Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period; 2. Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies); 3.Outpatient or hospital management; 4.Adults and children. Exclusion Criteria: None

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection (COVID-19) in Kidney Transplant Recipients: a Brazilian Multicenter Study
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : November 3, 2020
Estimated Study Completion Date : April 2, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Death [ Time Frame: Up to 3 months after resolution ]
    Death within 3 months after infection (Yes/No).

  2. Graft loss [ Time Frame: Up to 3 months after resolution ]
    Graft loss up to 3 months after infection (Yes/No).


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: Until discharge date, an average of 1 month ]
    Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 kidney transplant recipients confirmed by diagnostic test.
Criteria

Inclusion Criteria:

  1. Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period;
  2. Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies);
  3. Outpatient or hospital management;
  4. Adults and children.

Exclusion Criteria:

-


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): NCT04494776


Contacts
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Contact: Helio Tedesco +55 11 5087-8113 heliotedesco@medfarm.com.br
Contact: Monica Nakamura +55 11 5087 8318

Locations
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Brazil
Hospital do Rim Recruiting
São Paulo, Aão Paulo, Brazil, 04038-002
Sponsors and Collaborators
Helio Tedesco Silva Junior
Hospital do Rim e Hipertensão
Investigators
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Study Director: Jose Osmar Medina Hospital do Rim
Publications:

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Responsible Party: Helio Tedesco Silva Junior, Principal Investigator, Hospital do Rim e Hipertensão
ClinicalTrials.gov Identifier: NCT04494776    
Other Study ID Numbers: 30631820.0.1001.8098
First Posted: July 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
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
Keywords provided by Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão:
SARS-CoV-2 Infection
Kidney Transplant Infection
Kidney Transplant
Additional relevant MeSH terms:
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Infection
Communicable Diseases