Chronic Kidney DiseasesCCCRDQNCT05275595
COVID-19 Among Children With Chronic Renal Diseases in Qatar
An observational study of Chronic Kidney Diseases and COVID-19 Infection, run by Hamad Medical Corporation at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Kidney Diseases, COVID-19 Infection, Acute Kidney Injury
- What is being tested?
- Medical records review
- How many people
- 1,300 participants
- Where
- 1 siteQatar
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- All children and adolescents (≤ 18 years old).
- who have underlying kidney disease.
- laboratory-confirmed SARS-CoV-2 infection.
Who cannot join
- Patients with SARS-CoV-2 infection who developed AKI during the hospital stay but lacked evidence of pre-existing kidney disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Medical records review
- Medical subject headings
- Renal Insufficiency, Chronic, COVID-19, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical records reviewOther
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.
Medical records reviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| chronic renal disease with covid | all patients who have chronic kidney disease with COVID-19 infection Receives: Other: Medical records review | |
| chronic renal disease without covid | all patients who have chronic kidney disease without COVID-19 infection Receives: Other: Medical records review |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between chronic kidney disease and COVID-19 infection in children
There is an increased predisposition to COVID-19 infection in patients with CKD due to illness or treatment.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alhandi Omar Helal, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275595
- Sponsor's protocol ID
- MRC-01-22-052
- Acronym
- CCCRDQ
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of COVID-19 Among Children With Chronic Renal Diseases in Qatar
- ClinicalTrials.gov ID
- NCT05275595
- Acronym / sponsor ID
- CCCRDQ / MRC-01-22-052
- Conditions
- Chronic Kidney Diseases, COVID-19 Infection, Acute Kidney Injury, Chronic Renal Failure in Children, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic renal disease with covid | – | Other: Medical records reviewall patients who have chronic kidney disease with COVID-19 infection |
| chronic renal disease without covid | – | Other: Medical records reviewall patients who have chronic kidney disease without COVID-19 infection |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- All children and adolescents (≤ 18 years old).
- who have underlying kidney disease.
- laboratory-confirmed SARS-CoV-2 infection.
Key exclusion criteria (1 listed)
- Patients with SARS-CoV-2 infection who developed AKI during the hospital stay but lacked evidence of pre-existing kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical records reviewData 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. | Other | chronic renal disease with covid |
| Medical records reviewData 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. | Other | chronic renal disease without covid |
Primary outcome
The relationship between chronic kidney disease and COVID-19 infection in children
Time frame: 2 year
There is an increased predisposition to COVID-19 infection in patients with CKD due to illness or treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alhandi Omar Helal principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and COVID-19 Infection, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between chronic kidney disease and COVID-19 infection in children (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.