SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHelio Tedesco Silva Junior
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period;
Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies);
Outpatient or hospital management;
Adults and children.
Disqualifiers
None
Trial population
COVID-19 kidney transplant recipients confirmed by diagnostic test.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Death
Death within 3 months after infection (Yes/No).
Time frame
Up to 3 months after resolution2
Graft loss
Graft loss up to 3 months after infection (Yes/No).
Time frame
Up to 3 months after resolutionSecondary outcomes
1
Hospitalization
Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No).
Time frame
Until discharge date, an average of 1 monthSponsors and contacts
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Helio Tedesco Silva Junior
Lead sponsor
Hospital do Rim e Hipertensão
Sponsor institution
Hospital do Rim e Hipertensão
Collaborator
Source ClinicalTrials.gov