Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05275595 |
| Other study ID # |
MRC-01-22-052 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Hamad Medical Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
