NCT05817006

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

February 9, 2023

Last Update Submit

January 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postcovid syndrome in children

    Number of Participants with research of the bridge syndrome

    1 year

Study Arms (1)

Long-COVID-19

EXPERIMENTAL

conducting laboratory tests, questionnaires, physical examination

Genetic: Device

Interventions

DeviceGENETIC

research of the long-COVID-19 in the children

Long-COVID-19

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children from 6 to 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danija

Samara, Pestravka, 446160, Russia

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olga Borisova

    Doctor of Sciences, Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: laboratory and physical examination of postcovid syndrome in children aged 6 to 18 years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

April 18, 2023

Study Start

April 16, 2023

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

development of a unified integrated model for assessing neurological status, cognitive disorders, somatic disorders of organs and systems to identify patients at risk of chronic infection, prevent the development of such conditions, conduct early personal rehabilitation of children who have undergone COVID-19, and further develop methods for conducting medical examinations

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2 years
Access Criteria
available to everyone

Locations