Pediatric Respiratory DiseasesNCT04335773
COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology
An observational study of Pediatric Respiratory Diseases and COVID, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
Prospective cohort study of COVID-19 infection among children in Norway. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Respiratory Diseases, COVID, Fatigue Post Viral
- How many people
- 350 participants
- Where
- 1 siteNorway
- Study dates
- 3 Apr 2020to 31 Dec 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children seeking hospital care i Norway
Who may be able to join
- Suspected covid-19 infection and age 0-18 years
Who cannot join
- Age >18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus universistetssykehus
Lørenskog
Lise Beier Havdal, lisebeierommen@gmail.com
About this study
Prospective cohort study of COVID-19 infection among children in Norway.
Read the detailed description
This nation-wide, prospective cohort study of COVID-19 infection addresses three main issues: 1) Epidemiological risk factors; 2) Natural history (including immunological mechanisms and long term effects) and 3) Support of infection prevention. Also, the study focuses solely on children.
Children (0-18 years of age) admitted to hospital with suspected COVID-19 are eligible (Fig. 1). Those with confirmed COVID-19 serve as cases, whereas those with non-COVID-19 serve as controls; both groups will be followed prospectively for 6 months. Three objectives/Work Packages (WPs) are defined:
- In WP1, the investigators will investigate risk factors for severe outcome of the acute infection; potential risk factors include sex, age, comorbidities, initial clinical findings, infectious load, and genetic markers.
- In WP2, the investigators will investigate the immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
- In WP3, the investigators will investigate the prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
- Conditions
- Pediatric Respiratory Diseases, COVID, Fatigue Post Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sars-CoV-2 positive | Children positive for SARS-CoV-2 | |
| SARS-CoV-2 negative | Children negative SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors for severe infection
Identify comorbidities predisposing for severe infection
Measured: 2030
Immunulogical mechanisms
Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
Measured: 2030
Long term outcome
prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
Measured: 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start3 Apr 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Respiratory DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Stavanger HF, Haukeland University Hospital, University Hospital of North Norway, Alesund Hospital, Norwegian Institute of Public Health, The University of New South Wales, University of Bristol, Sykehuset Ostfold, Nordlandssykehuset HF, Vestre Viken Hospital Trust, Helse Fonna, Helse Nord-Trøndelag HF, Oslo University Hospital, Sykehuset Innlandet HF
- Responsible party
- Principal investigator, Christopher Inchley, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335773
- Sponsor's protocol ID
- 20/03794
- Status last verified
- Feb 2022
- First submitted
- 3 Apr 2020
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology
- ClinicalTrials.gov ID
- NCT04335773
- Acronym / sponsor ID
- 20/03794
- Conditions
- Pediatric Respiratory Diseases, COVID, Fatigue Post Viral
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Stavanger HF, Haukeland University Hospital, University Hospital of North Norway, Alesund Hospital, Norwegian Institute of Public Health, The University of New South Wales, University of Bristol, Sykehuset Ostfold, Nordlandssykehuset HF, Vestre Viken Hospital Trust, Helse Fonna, Helse Nord-Trøndelag HF, Oslo University Hospital, Sykehuset Innlandet HF
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Apr 2020 (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.
Prospective cohort study of COVID-19 infection among children in Norway.
Detailed description
This nation-wide, prospective cohort study of COVID-19 infection addresses three main issues: 1) Epidemiological risk factors; 2) Natural history (including immunological mechanisms and long term effects) and 3) Support of infection prevention. Also, the study focuses solely on children.
Children (0-18 years of age) admitted to hospital with suspected COVID-19 are eligible (Fig. 1). Those with confirmed COVID-19 serve as cases, whereas those with non-COVID-19 serve as controls; both groups will be followed prospectively for 6 months. Three objectives/Work Packages (WPs) are defined:
- In WP1, the investigators will investigate risk factors for severe outcome of the acute infection; potential risk factors include sex, age, comorbidities, initial clinical findings, infectious load, and genetic markers.
- In WP2, the investigators will investigate the immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
- In WP3, the investigators will investigate the prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sars-CoV-2 positive | – | –Children positive for SARS-CoV-2 |
| SARS-CoV-2 negative | – | –Children negative SARS-CoV-2 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children seeking hospital care i Norway
Key inclusion criteria (1 listed)
- Suspected covid-19 infection and age 0-18 years
Key exclusion criteria (1 listed)
- Age >18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk Factors for severe infection
Time frame: 2030
Identify comorbidities predisposing for severe infection
Immunulogical mechanisms
Time frame: 2030
Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
Long term outcome
Time frame: 2030
prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Respiratory Diseases and COVID, run by University Hospital, Akershus at 1 site in Norway.
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: looking for participants now, as of the sponsor's last update on 16 Feb 2022. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Inchley, Phd (90069276, chris.inchley@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors for severe infection (time frame: 2030). The study lists 3 primary outcomes in all. 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 16 Feb 2022.