Long COVIDNCT05817006
Research of the Long-COVID-19 Syndrome in the Children
A study testing Device in people with Long COVID, run by Samara State Medical University at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Long COVID
- What is being tested?
- Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteRussia
- Study dates
- 16 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children from 6 to 18 years
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Diagnosis, Prognosis and Prevention of Postcovid Syndrome in Children During the Pandemic of the New Coronavirus Infection COVID-19
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.
Read the 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, researchers 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.
- Conditions
- Long COVID
- Being tested
- Device
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceGenetic
research of the long-COVID-19 in the children
| Study group | Role | What they receive |
|---|---|---|
| Long-COVID-19 | Experimental | conducting laboratory tests, questionnaires, physical examination Receives: Genetic: Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
postcovid syndrome in children
Number of Participants with research of the bridge syndrome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start16 Apr 2023
- Primary completion30 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- laboratory and physical examination of postcovid syndrome in children aged 6 to 18 years
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Borisova, Study director, Doctor of Sciences, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817006
- Sponsor's protocol ID
- qwe123456789$
- Status last verified
- Jan 2025
- First submitted
- 9 Feb 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis, Prognosis and Prevention of Postcovid Syndrome in Children During the Pandemic of the New Coronavirus Infection COVID-19
- ClinicalTrials.gov ID
- NCT05817006
- Acronym / sponsor ID
- qwe123456789$
- Conditions
- Long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, researchers 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- laboratory and physical examination of postcovid syndrome in children aged 6 to 18 years
| Arm | Type | Receives |
|---|---|---|
| Long-COVID-19 | Experimental | Genetic: Deviceconducting laboratory tests, questionnaires, physical examination |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children from 6 to 18 years
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deviceresearch of the long-COVID-19 in the children | Genetic | Long-COVID-19 |
Primary outcome
postcovid syndrome in children
Time frame: 1 year
Number of Participants with research of the bridge syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Borisova study director
Doctor of Sciences, Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device in people with Long COVID, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postcovid syndrome in children (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.