Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05817006 |
| Other study ID # |
qwe123456789$ |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 16, 2023 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
January 2023 |
| Source |
Samara State Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
During the pandemic of the new coronavirus infection COVID-19 in the world community, in the
Russian Federation, in particular in the Samara region throughout the pandemic period from
the end of 2019, when the first outbreak of a new coronavirus infection occurred in Wuhan
(Hubei Province) in the People's Republic of China, the main focus on prevention (development
of modern vaccines), diagnosis, treatment and further rehabilitation was done on the adult
population. Children acted mainly as carriers of this infection and the manifestation of the
disease usually occurred in most cases (not counting children with comorbid conditions) in a
mild or latent form. At the moment, after 2 years, we can say that postcovid syndrome also
occurs in children, regardless of the severity of the disease.
Description:
. During the pandemic of the new coronavirus infection COVID-19 in the world community, in
the Russian Federation, in particular in the Samara region throughout the pandemic period
from the end of 2019, when the first outbreak of a new coronavirus infection occurred in
Wuhan (Hubei Province) in the People's Republic of China, the main focus on prevention
(development of modern vaccines), diagnosis, treatment and further rehabilitation was done on
the adult population. Children acted mainly as carriers of this infection and the
manifestation of the disease usually occurred in most cases (not counting children with
comorbid conditions) in a mild or latent form. At the moment, after 2 years, we can say that
postcovid syndrome also occurs in children, regardless of the severity of the disease.
Post-COVID syndrome (Post-COVID syndrome, Long COVID) is a long-term symptoms lasting 12 or
more weeks. In most cases, it manifests itself as a disorder of autonomic and psychological
functions (cognitive impairment), to a lesser extent somatic disorders, prolonged
subfebrility.
If you look at the world statistics, according to the World Health Organization, from
December 2019 to October 2021, the number of sick children was:
- from 0 to 5 years (children under one year and younger) - 1,890,756, which is only 2% of
all reported cases of COVID-19 in the entire world community. The mortality rate in this
group of children was 1,797, or 0.1% of the registered deaths worldwide.
- from 5 to 14 years old (older children) - 7,058,748, the indicator has slightly
increased and accounts for 7% of all reported cases of COVID-19 in the entire world
community. The mortality rate in this group of children is slightly lower, amounting to
1,328, or, as in the previous group, 0.1% of the registered deaths worldwide.
- from 15 to 24 years old (older adolescents and young people, as there is a different age
group in the world community) - 14,819,320, which is 15% of all reported cases of
COVID-19 in the world. Mortality in this group is 7,023, or 0.4% of all registered
deaths in the world. The total mortality among children, adolescents and young people
aged 0 to 25 years was less than 0.5% of the registered deaths in the world.
Worldwide, and in the Russian Federation in particular, in 2022, the incidence of COVID-19,
according to WHO, among children has increased sharply against the background of an increase
in the incidence of the Omicron strain at a time when most countries have weakened public
health and social measures. For example, in the United States, by July 2022, there were
14,003,497 cases of the disease in children, and the children were 18,6% (14 003 497 /75 463
921) of all registered cases, with a total of 18,605 cases per 100,000 children in the
population. Worldwide, by July 24, 2022, the proportion of children under the age of 5 and
children aged 5 to 14 years was 2.47% and 10.44%, respectively. Adolescents and young people
aged 15 to 24 accounted for 13.91% of all cases. Children aged 5 years and younger account
for 0.11% of all deaths in the world, while children aged 5 to 14 years account for 0.089%,
and adolescents and young people account for 0.37% of all reported deaths in the world.
In the Russian Federation, there are no statistics on the incidence of a new coronavirus
infection in children, there are separate data by region, but there are no general
statistics. In this regard, it can be assumed that a large number of children who have
suffered COVID-19 is not taken into account, so it is necessary to investigate the postcovid
syndrome not only in children who have suffered a new coronavirus infection with confirmed
laboratory data, but also in those who have suffered it asymptomatically or under the guise
of a common respiratory infection in order to identify long-term and chronic symptoms
COVID-19 in children. Having studied the main biological mechanisms that cause these
symptoms, we will be able to identify patients at risk of chronic infection, prevent the
development of such conditions and will be able to carry out early rehabilitation of children
who have suffered COVID-19.
