Clinical Characteristics of Coronavirus Disease 2019 in China.
Wei-Jie Guan, Zheng-Yi Ni, Yu Hu...
https://pubmed.ncbi.nlm.nih.gov/32109013Actively Recruiting
All Genders
ID04494776
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection (COVID-19) in Kidney Transplant Recipients: a Brazilian Multicenter Study
Led by Helio Tedesco Silva Junior · Updated on 2024-11-08
500
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
H
Helio Tedesco Silva Junior
Lead Sponsor
H
Hospital do Rim e Hipertensão
Collaborating Sponsor
AI-Summary
What this Trial Is About
COVID-19 is a highly contagious viral illness caused by the SARS-CoV-2 coronavirus, with main symptoms including fever and respiratory problems. Patients with pre-existing conditions like diabetes, hypertension, heart disease, lung diseases, chronic kidney disease, and weakened immune systems may experience worse outcomes. Kidney transplant recipients use immunosuppressive drugs to prevent organ rejection, which may change how COVID-19 affects them. Currently, limited information exists about COVID-19 outcomes in kidney transplant patients, so this study aims to detail their clinical and laboratory features and outcomes in a national multicenter group. The study observes kidney transplant recipients of any follow-up period who test positive for COVID-19 through viral load, antigen, or antibody tests. It includes both outpatients and hospitalized patients across all ages, including adults and children. The study does not involve treatments but collects data to understand the condition's impact on this population. Participants will have their clinical data collected regarding the need for mechanical ventilation, dialysis, ICU admission, and outcomes such as death or graft loss up to three months after COVID-19 resolution. Hospitalization duration is also tracked until discharge. The study follows patients for up to three months after recovery to monitor health outcomes and organ function.
CONDITIONS
Brief Title
SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Kidney transplant recipients, including multi-organ recipients, at any follow-up period
- Positive diagnostic test for COVID-19 by viral load, antigen, or antibody detection
- Outpatient or hospital management for COVID-19
- Adults and children
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for confirmation of eligibility including COVID-19 test results
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo diagnostic testing for COVID-19 to confirm infection status.
1 to 2 visits depending on testing method
Monitoring
Duration - Until hospital discharge or clinical resolution, approximately 1 month
Participants are observed during outpatient or hospital management of COVID-19, including assessments of clinical and laboratory conditions.
Regular visits or assessments during outpatient or hospital care
Long-term Monitoring
Duration - Up to 3 months after resolution
Participants are followed for up to 3 months after resolution of COVID-19 to evaluate outcomes such as death and graft loss.
Periodic follow-up visits or assessments for up to 3 months
Trial Site Locations
Total: 1 location
1
Hospital do Rim
São Paulo, Aão Paulo, Brazil, 04038-002
Actively Recruiting
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Research Team
H
Helio Tedesco
M
Monica Nakamura
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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P Conti, G Ronconi, A Caraffa...
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Wenhua Liang, Weijie Guan, Ruchong Chen...
https://pubmed.ncbi.nlm.nih.gov/32066541Successful recovery of COVID-19 pneumonia in a renal transplant recipient with long-term immunosuppression.
Lan Zhu, Xizhen Xu, Ke Ma...
https://pubmed.ncbi.nlm.nih.gov/32181990Case report of COVID-19 in a kidney transplant recipient: Does immunosuppression alter the clinical presentation?
Elena Guillen, Gaston J Pineiro, Ignacio Revuelta...
https://pubmed.ncbi.nlm.nih.gov/32198834Development and validation of a simple web-based tool for early prediction of COVID-19-associated death in kidney transplant recipients.
Luis Gustavo Modelli de Andrade, Tainá Veras de Sandes-Freitas, Lúcio R Requião-Moura...
https://pubmed.ncbi.nlm.nih.gov/34416075