SARS CoV 2 InfectionNCT05186597
Incidence of MIS-C and Other Complications Following SARS-CoV-2 Infection
An observational study of SARS CoV 2 Infection and Multisystem Inflammatory Disease, Pediatric, COVID-19 Related, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. It has been reported to occur in approximately one of 3,000 to 4,000 unvaccinated children during the COVID-19 waves dominated by variant Alpha of SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- SARS CoV 2 Infection, Multisystem Inflammatory Disease, Pediatric, COVID-19 Related, Multisystem Inflammatory Syndrome in Children
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2021to 31 Dec 2024
- Phase
- Observational
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children and adolescents in the whole population of Denmark
Who may be able to join
- MIS-C according to criteria devised by the World Health Organization and Centers for Disease Control and Prevention (CDC)
- Invasive bacterial infections and viral infections secondary to SARS-CoV-2 or as consequence of SARS-CoV-2 lock down
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Ulrikka Nygaard, MD, 35453545 ext. +45, ulrikka.nygaard@regionh.dk
About this study
Official title: Incidence of Multisystem Inflammatory Syndrome in Children (MIS-C) and Other Complications Following SARS-CoV-2. A Nationwide Population-based Study.
Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. It has been reported to occur in approximately one of 3,000 to 4,000 unvaccinated children during the COVID-19 waves dominated by variant Alpha of SARS-CoV-2. However, the incidences following SARS-CoV-2 infection with variant delta and omicron, as well as among vaccinated children and adolescents with SARS-CoV-2 is yet unexplored.
The investigators aim to estimate the incidence of MIS-C and in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, based on a nationwide prospective population-based cohort study.
Read the detailed description
AIM The project seeks to estimate the incidences of MIS-C in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, .
HYPOTHESIS The incidences of MIS-C following SARS-CoV-2 variant delta and omicron are similar to the risk following variant alpha in unvaccinated children and adolescents, while the incidences among vaccinated children and adolescents are significantly lower. Further, severe complications to SARS-CoV-2, e.g. PVL producing S aur. infection is increased, as well as severe RSV-complication in older children in the post-COVID-lock down RSV epidemic
METHOD Prospective nationwide population-based cohort study of all individuals aged 0-17 years hospitalized due to MIS-C, or other complications to SARS-CoV-2 in the period August 15, 2021 to August 14, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of patients with MIS-C and other complications to SARS-CoV-2, including complications secondary to the lock-down.
To calculate the incidence of MIS-C among Danish children and adolescents, the number of individuals who has tested positive for a SARS-CoV-2 infection in the period July 15 2021 to July 14 2022 will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut. From the Statens Serum Institut and the Danish Microbiological Departments, the numbers bacterial infections including PVL-producing S aureus bacteremias and RSV infection will be obtained.
- Conditions
- SARS CoV 2 Infection, Multisystem Inflammatory Disease, Pediatric, COVID-19 Related, Multisystem Inflammatory Syndrome in Children, COVID-19 Pandemic
- Keywords
- SARS CoV 2 Infection, Multisystem Inflammatory Syndrome in Children, COVID-19 Pandemic
- Medical subject headings
- COVID-19, pediatric multisystem inflammatory disease, COVID-19 related
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MIS-C, invasive bacterial and viral infections
Measured: August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Jul 2021
- Primary completion14 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark, Ministry of Education, Denmark
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186597
- Sponsor's protocol ID
- H-20028631_MIS-C
- Status last verified
- Feb 2023
- First submitted
- 9 Jan 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nygaard U, Hartling UB, Nielsen J, Vestergaard LS, Dungu KHS, Nielsen JSA, Sellmer A, Matthesen AT, Kristensen K, Holm M. Hospital admissions and need for mechanical ventilation in children with respiratory syncytial virus before and during the COVID-19 pandemic: a Danish nationwide cohort study. Lancet Child Adolesc Health. 2023 Mar;7(3):171-179. doi: 10.1016/S2352-4642(22)00371-6. Epub 2023 Jan 9.
PubMed 36634692Nygaard U, Holm M, Hartling UB, Glenthoj J, Schmidt LS, Nordly SB, Matthesen AT, von Linstow ML, Espenhain L. Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study. Lancet Child Adolesc Health. 2022 Jul;6(7):459-465. doi: 10.1016/S2352-4642(22)00100-6. Epub 2022 May 6.
PubMed 35526537
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Multisystem Inflammatory Syndrome in Children (MIS-C) and Other Complications Following SARS-CoV-2. A Nationwide Population-based Study.
- ClinicalTrials.gov ID
- NCT05186597
- Acronym / sponsor ID
- H-20028631_MIS-C
- Conditions
- SARS CoV 2 Infection, Multisystem Inflammatory Disease, Pediatric, COVID-19 Related, Multisystem Inflammatory Syndrome in Children, COVID-19 Pandemic
- Keywords
- SARS CoV 2 Infection, Multisystem Inflammatory Syndrome in Children, COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark, Ministry of Education, Denmark
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 14 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 2022 (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.
Multisystem inflammatory syndrome in children (MIS-C) is a rare severe complication to SARS-CoV-2 infection in children. It has been reported to occur in approximately one of 3,000 to 4,000 unvaccinated children during the COVID-19 waves dominated by variant Alpha of SARS-CoV-2. However, the incidences following SARS-CoV-2 infection with variant delta and omicron, as well as among vaccinated children and adolescents with SARS-CoV-2 is yet unexplored.
The investigators aim to estimate the incidence of MIS-C and in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, based on a nationwide prospective population-based cohort study.
Detailed description
AIM The project seeks to estimate the incidences of MIS-C in vaccinated and unvaccinated children and adolescents following variants delta and omicron, and other complications of SARS-CoV-2 including complication due to SARS-CoV-2 lock-down, .
HYPOTHESIS The incidences of MIS-C following SARS-CoV-2 variant delta and omicron are similar to the risk following variant alpha in unvaccinated children and adolescents, while the incidences among vaccinated children and adolescents are significantly lower. Further, severe complications to SARS-CoV-2, e.g. PVL producing S aur. infection is increased, as well as severe RSV-complication in older children in the post-COVID-lock down RSV epidemic
METHOD Prospective nationwide population-based cohort study of all individuals aged 0-17 years hospitalized due to MIS-C, or other complications to SARS-CoV-2 in the period August 15, 2021 to August 14, 2022. The setting is a multicenter study including all 18 Danish Pediatric Departments, providing 24 hours emergency service, and in- and out-patient treatment for all Danish inhabitants aged ≤ 17 years. As part of a pediatric nationwide COVID-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of patients with MIS-C and other complications to SARS-CoV-2, including complications secondary to the lock-down.
To calculate the incidence of MIS-C among Danish children and adolescents, the number of individuals who has tested positive for a SARS-CoV-2 infection in the period July 15 2021 to July 14 2022 will be attained from the National COVID-19-vaccine Database at the Statens Serum Institut. From the Statens Serum Institut and the Danish Microbiological Departments, the numbers bacterial infections including PVL-producing S aureus bacteremias and RSV infection will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children and adolescents in the whole population of Denmark
Key inclusion criteria (2 listed)
- MIS-C according to criteria devised by the World Health Organization and Centers for Disease Control and Prevention (CDC)
- Invasive bacterial infections and viral infections secondary to SARS-CoV-2 or as consequence of SARS-CoV-2 lock down
Key exclusion criteria (1 listed)
- -
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
Incidence of MIS-C, invasive bacterial and viral infections
Time frame: August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 36634692Nygaard U, Hartling UB, Nielsen J, Vestergaard LS, Dungu KHS, Nielsen JSA, Sellmer A, Matthesen AT, Kristensen K, Holm M. Hospital admissions and need for mechanical ventilation in children with respiratory syncytial virus before and during the COVID-19 pandemic: a Danish nationwide cohort study. Lancet Child Adolesc Health. 2023 Mar;7(3):171-179. doi: 10.1016/S2352-4642(22)00371-6. Epub 2023 Jan 9.
- Derived from this study: PubMed 35526537Nygaard U, Holm M, Hartling UB, Glenthoj J, Schmidt LS, Nordly SB, Matthesen AT, von Linstow ML, Espenhain L. Incidence and clinical phenotype of multisystem inflammatory syndrome in children after infection with the SARS-CoV-2 delta variant by vaccination status: a Danish nationwide prospective cohort study. Lancet Child Adolesc Health. 2022 Jul;6(7):459-465. doi: 10.1016/S2352-4642(22)00100-6. Epub 2022 May 6.
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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.
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 SARS CoV 2 Infection and Multisystem Inflammatory Disease, Pediatric, COVID-19 Related, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrikka Nygaard (40794656, Ulrikka@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MIS-C, invasive bacterial and viral infections (time frame: August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186597, which also lists 2 linked publications.
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 Feb 2023.