- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05275595
COVID-19 Among Children With Chronic Renal Diseases in Qatar (CCCRDQ)
A Descriptive Study of COVID-19 Among Children With Chronic Renal Diseases in Qatar
Coronavirus disease 2019 is a novel viral disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 virus. The original cases occurred in Wuhan, China, in December 2019 and rapidly spread to other areas worldwide, constituting a pandemic with unimaginable health and economic consequences. the World Health Organization elevated the disease to the category of a pandemic on March 11, 2020.
In children, the reported mortality rates were far below 1%, while in people above the age of 70 years it was above 5% or higher. So, in this retrospective study, the investigators describe the clinical features and outcomes of children with chronic kidney diseases who were diagnosed with Severe Acute Respiratory Syndrome Coronavirus 2 infection at pediatric centers in Doha from 1st March 2020 till January 20th, 2022. This review looks into the literature on pediatric patients with chronic kidney diseases to verify whether they were more prone to developing more severe symptoms when diagnosed with Coronavirus disease 2019 compared to children without chronic kidney diseases and adults with chronic kidney diseases, and the Prevalence of COVID-19 infection between patients with chronic kidney diseases, and the role of COVID-19 infection in increasing the relapses and deterioration of chronic kidney diseases.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this retrospective study investigators will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory-confirmed SARS-CoV-2 infection who were treated at Hamad General Hospital, in Doha, Qatar during this pandemic using the electronic medical records from 1st March 2020 till January 20th, 2022. Indications for testing patients for SARS CoV-2 infection included:
- Clinical features suggestive of COVID-19 (fever, cough, dyspnea, rhinorrhea, sore throat, diarrhea, myalgia, anosmia, or ageusia).
- Close contact (within 6-ft of an infected person for 15 min or longer) within an individual diagnosed with SARS-CoV-2 infection.
- Admission for management of the underlying disease. Testing for SARS-CoV-2 infection was performed on nasal and oropharyngeal swabs using reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen test.
Indications for hospital admission were:
- symptomatic infection, particularly in an immunosuppressed host.
- management of the underlying illness.
- inability to ensure home isolation. Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, the severity of COVID-19 and associated complications, testing methods for SARS-CoV-2 virus and duration of RT-PCR positivity, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. In patients with nephrotic syndrome, the presence of nephrotic-range proteinuria at evaluation at onset, relapse, or following non-response to immunosuppression, was considered as 'relapse'.
The Patients will be followed up until discharge, death, or 4weeks after diagnosis of COVID-19, whichever was earlier, until 20 January. Hypertension was defined using standard guidelines. The estimated glomerular filtration rate (eGFR) was calculated using the modified Schwartz formula.
Investigators will look for the clinical manifestations, radiological and laboratory findings, severity of COVID-19 infection, prevalence and difference between waves of the pandemic, median age, gender, and ethnic background. Underlying illness, renal treatment, reinfection, correlation with vaccination.
Participants are divided into three groups; first wave, second wave, and third wave
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Doha, Qatar, 3050
- Hamad Medical Corporation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
This retrospective review of electronic medical records from the Pediatric nephrology division, Pediatrics division, Hamad General hospital in Doha, Qatar, will include all children and adolescents (≤ 18 years old) with pre-existing CKD and laboratory-confirmed SARS-CoV-2 infection between March 2020, to 20 January 2022.
Approximately 100 eligible records will be reviewed. Data collection will be done by the investigators for all participants.
Description
Inclusion Criteria:
- All children and adolescents (≤ 18 years old).
- who have underlying kidney disease.
- laboratory-confirmed SARS-CoV-2 infection.
Exclusion Criteria:
- Patients with SARS-CoV-2 infection who developed AKI during the hospital stay but lacked evidence of pre-existing kidney disease.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
chronic renal disease with covid
all patients who have chronic kidney disease with COVID-19 infection
|
Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, severity of COVID-19 and associated complications, testing methods for SARS-CoV-2 virus and duration of RT-PCR positivity, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. In patients with nephrotic syndrome, the presence of nephrotic-range proteinuria at evaluation at onset, relapse or following non-response to immunosuppression, was considered as 'relapse'. The Patients will be followed up until discharge, death or 4weeks after diagnosis of COVID-19, whichever was earlier, until 20 January.
Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, associated complications, therapy received, and duration of hospital stay.
Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5.
|
|
chronic renal disease without covid
all patients who have chronic kidney disease without COVID-19 infection
|
Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, severity of COVID-19 and associated complications, testing methods for SARS-CoV-2 virus and duration of RT-PCR positivity, therapy received, and duration of hospital stay. Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5. In patients with nephrotic syndrome, the presence of nephrotic-range proteinuria at evaluation at onset, relapse or following non-response to immunosuppression, was considered as 'relapse'. The Patients will be followed up until discharge, death or 4weeks after diagnosis of COVID-19, whichever was earlier, until 20 January.
Data on clinical and laboratory findings are reviewed from medical records for details of underlying disease, associated complications, therapy received, and duration of hospital stay.
Underlying CKD was categorized as nephrotic syndrome, other kidney diseases with CKD stage 1-5.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The relationship between chronic kidney disease and COVID-19 infection in children
Time Frame: 2 year
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There is an increased predisposition to COVID-19 infection in patients with CKD due to illness or treatment.
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2 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mahmoud Alhandi Omar Helal, Hamad Medical Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- COVID-19
- Kidney Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Acute Kidney Injury
Other Study ID Numbers
- MRC-01-22-052
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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