Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04788394 |
| Other study ID # |
MRC01-21-089 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Hamad Medical Corporation |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
COVID-19 usually causes respiratory and gastrointestinal symptoms, Clinical features range
from a common cold to severe diseases such as bronchitis, pneumonia, severe acute respiratory
distress syndrome, multi-organ failure, and even death. SARS-CoV, MERS-CoV, and SARS-CoV-2
seem to less commonly affect children and to cause fewer symptoms and less severe disease in
this age group compared with adults and are associated with much lower case-fatality rates.
Coronaviruses are a large family of enveloped, single-stranded, zoonotic RNA viruses.
Clinicians have observed many extrapulmonary manifestations of COVID-19, as hematologic,
cardiovascular, renal, and gastrointestinal and hepatobiliary, endocrinologic, neurologic,
ophthalmologic, and dermatologic systems can all be affected.
Acute kidney injury (AKI) is a frequent complication of COVID-19 and is associated with
mortality. In adults, the incidence of AKI in hospitalized patients with COVID-19 ranged from
0.5% to 29% and occurred within a median of 7-14 days after admission. Studies from the USA
have reported much higher rates of AKI. In a study of nearly 5,500 patients admitted with
COVID-19 in a New York City hospital system, AKI occurred in 37%, with 14% of the patients
requiring dialysis. AKI occurred at much higher rates in critically ill patients admitted to
New York City hospitals, ranging from 78% to 90%. Of 257 adult patients admitted to ICUs in a
study from New York City, 31% received renal replacement therapy (RRT). Furthermore,
hematuria has been reported in nearly half of patients with COVID-19, and proteinuria has
been reported in up to 87% of critically ill patients with COVID-19 (11). Hyperkalemia and
acidosis are common electrolyte abnormalities seen in patients with COVID-19, even among
patients without AKI. COVID-19 is also increasingly reported among patients with end-stage
renal disease and kidney transplant recipients, with higher mortality rates than those seen
in the general population.
Children and adolescents with COVID-19 fare considerably better than adults, with mortality
rates in pediatric patients (age <18 years) of less than 1% reported in early studies . The
most common clinical features in children described in the literature are fever, dry cough,
and pneumonia . However, multisystem involvement is increasingly being recognized, including
the development of hyperinflammatory shock.
In other studies, acute kidney injury has been reported in adult patients with COVID-19, with
a high prevalence across inpatient admissions (≤7%) and admissions to adult intensive care
units (ICUs; ≤23%), as first reported in Wuhan, China . In adult patients with COVID-19,
acute kidney injury is related to increased mortality risk, even after adjustment for age,
sex, and comorbidities. In addition, a large proportion of adults have proteinuria (44%) and
hematuria (27%) at presentation, despite an elevated serum creatinine prevalence of only 16%
.
In children, there is scanty data compared to adults, Douglas et al studied 52 pediatric
patients (ages 0-16 years) admitted to Great Ormond Street Hospital for Children NHS
Foundation Trust (London, UK) since March 25, 2020, with confirmed severe acute respiratory
syndrome coronavirus infection, and diagnosed by either a positive PCR result or
seropositivity. Of the 52 inpatients, 24 (46%) had a serum creatinine greater than the upper
limit of reference interval (ULRI), 22 [42%] had proteinuria, and hematuria was found in 40
[77%] patients. Qui and colleagues (18) did not find any renal dysfunction in 36 hospitalized
pediatric patients (ages 0-16 years) with COVID-19 in China. Renal dysfunction defined by a
serum creatinine greater than 110 μmol/L or serum urea greater than 7 mmol/L.
This retrospective, exploratory, descriptive study aims to determine the renal involvement in
all pediatric patients who were hospitalized with COVID-19 in Qatar.
