Research of the Long-COVID-19 Syndrome in the Children

Sponsor
Samara State Medical University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05817006
Collaborator
(none)
30
1
1
32.5
0.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Device
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
laboratory and physical examination of postcovid syndrome in children aged 6 to 18 yearslaboratory and physical examination of postcovid syndrome in children aged 6 to 18 years
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Early Diagnosis, Prognosis and Prevention of Postcovid Syndrome in Children During the Pandemic of the New Coronavirus Infection COVID-19
Actual Study Start Date :
Apr 16, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Long-COVID-19

conducting laboratory tests, questionnaires, physical examination

Other: Device
research of the long-COVID-19 in the children

Outcome Measures

Primary Outcome Measures

  1. postcovid syndrome in children [1 year]

    Number of Participants with research of the bridge syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

• children from 6 to 18 years

Exclusion Criteria:

• no

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danija Samara Pestravka Russian Federation 446160

Sponsors and Collaborators

  • Samara State Medical University

Investigators

  • Study Director: Olga Borisova, Doctor of Sciences, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samara State Medical University
ClinicalTrials.gov Identifier:
NCT05817006
Other Study ID Numbers:
  • qwe123456789$
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 18, 2023