COVID-19 Among Children With Chronic Renal Diseases in Qatar

NCT ID: NCT05275595

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

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

Conditions

Chronic Kidney Diseases; COVID-19 Infection; Acute Kidney Injury; Chronic Renal Failure in Children; COVID-19 Pandemic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

chronic renal disease with covid

all patients who have chronic kidney disease with COVID-19 infection

Medical records review

Intervention Type: OTHER

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.

chronic renal disease without covid

all patients who have chronic kidney disease without COVID-19 infection

Medical records review

Intervention Type: OTHER

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.

Interventions

Medical records review

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.

Intervention Type: OTHER

Medical records review

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Alhandi Omar Helal

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

Other Identifiers

MRC-01-22-052

Identifier Type: -

Identifier Source: org_study_id