NCT04788394

Brief Summary

Covid-19 is an important human and animal pathogen, it mostly causes respiratory and gastrointestinal symptoms. Clinical features range from a common cold to severe diseases such as severe acute respiratory distress syndrome, bronchitis, pneumonia, multi-organ failure, and even death. It seems to be less commonly affecting children and to cause fewer symptoms and less severe disease in this age group compared with adults. Clinicians have observed many extrapulmonary manifestations of COVID-19, as hematologic, cardiovascular, renal, gastrointestinal and hepatobiliary, endocrinologic, neurologic, ophthalmologic, and dermatologic systems can all be affected. This retrospective study that will be conducted at Hamad General Hospital in Qatar, aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 from March 1, 2020, to January 1, 2021.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 25, 2023

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 7, 2021

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • determine the prevalence of renal dysfunction in hospitalized children with COVID19 in Qatar.

    explore and describe the rate of renal symptoms and signs, and severity in pediatric patients admitted to the hospital with COVID 19 in Qatar . The relation between severity of disease and age , weight , gender ,and nationality of participants .

    1 year

Interventions

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 since 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 \[40\]. * Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine:

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 since 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 \[40\]. * Admission for management of the underlying disease. le against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI. to determine:

Eligibility Criteria

Age1 Day - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

This retrospective review of electronic medical records from the pediatric division, Hamad General hospital in Doha, Qatar, will include all hospitalized children (0-14 years) who were diagnosed with COVID-19 between March 1, 2020, to January 1, 2021. Data collection will be done by co-investigators for all patients.

You may qualify if:

  • All pediatric patients with COVID-19 were admitted to Hamad Hospital from (0 to 14) years, using the electronic medical records (Cerner), over that time period (from March 1, to January 1, 2021), with one of the following:
  • Proteinuria: (≥1+) on dipstick analysis.
  • Hematuria: ≥ 5 RBC/HPF.
  • Sterile Pyuria: ≥ 5 WBC/HPF or ≥10 WBC/mm3 with negative urine culture (44).
  • Hypernatremia :\> 145meq/l.
  • Hyponatremia: \< 135 meq/l.
  • Hypokalemia :\< 3.5meq/l.
  • Metabolic acidosis (ph \<7.35).
  • Elevated serum creatinine :\> upper limit of reference interval (ULRI) values.
  • Elevated serum urea: \> 7 mmol/l.
  • Urine specific gravity (SG) \<1.003.

You may not qualify if:

  • \* Patient with previous chronic kidney diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad General corporation

Doha, 3050, Qatar

Location

MeSH Terms

Conditions

Acute Kidney InjuryCOVID-19Renal InsufficiencyCoronavirus Infections

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mahmoud Alhandi Omar Helal

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR
  • Mahmoud Helal

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 9, 2021

Study Start

March 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 25, 2023

Record last verified: 2021-03

Locations