SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: SARS-CoV-2 Infection, Kidney Transplant Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection (COVID-19) in Kidney Transplant Recipients: a Brazilian Multicenter Study
Overview
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.
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
Primary outcome measures
- Death [Time frame: Up to 3 months after resolution]
- Graft loss [Time frame: Up to 3 months after resolution]
Secondary outcome measures (1)
- Hospitalization [Time frame: Until discharge date, an average of 1 month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- Hospital do Rim — São Paulo
Publications
- Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 PMID 32109013
- Conti P, Ronconi G, Caraffa A, Gallenga CE, Ross R, Frydas I, Kritas SK. Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies. J Biol Regul Homeost Agents. 2020 March-April,;34(2):327-331. doi: 10.23812/CONTI-E. PMID 32171193
- D'Antiga L. Coronaviruses and Immunosuppressed Patients: The Facts During the Third Epidemic. Liver Transpl. 2020 Jun;26(6):832-834. doi: 10.1002/lt.25756. Epub 2020 Apr 24. No abstract available. PMID 32196933
- Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available. PMID 32066541
- Zhu L, Xu X, Ma K, Yang J, Guan H, Chen S, Chen Z, Chen G. Successful recovery of COVID-19 pneumonia in a renal transplant recipient with long-term immunosuppression. Am J Transplant. 2020 Jul;20(7):1859-1863. doi: 10.1111/ajt.15869. Epub 2020 Mar 31. PMID 32181990
- Guillen E, Pineiro GJ, Revuelta I, Rodriguez D, Bodro M, Moreno A, Campistol JM, Diekmann F, Ventura-Aguiar P. Case report of COVID-19 in a kidney transplant recipient: Does immunosuppression alter the clinical presentation? Am J Transplant. 2020 Jul;20(7):1875-1878. doi: 10.1111/ajt.15874. Epub 2020 Apr 9. PMID 32198834
- Modelli de Andrade LG, de Sandes-Freitas TV, Requiao-Moura LR, Viana LA, Cristelli MP, Garcia VD, Alcantara ALC, Esmeraldo RM, Abbud Filho M, Pacheco-Silva A, de Lima Carneiro ECR, Manfro RC, Costa KMAH, Simao DR, de Sousa MV, Santana VBBM, Noronha IL, Romao EA, Zanocco JA, Arimatea GGQ, De Boni Monteiro de Carvalho D, Tedesco-Silva H, Medina-Pestana J; COVID-19-KT Brazil. Development and validati PMID 34416075
Identifiers
NCT: NCT04494776 · 30631820.0.1001.8098