Incidence of MIS-C and Other Complications Following SARS-CoV-2 Infection
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| ClinicalTrials.gov Identifier: NCT05186597 |
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Recruitment Status :
Recruiting
First Posted : January 11, 2022
Last Update Posted : February 23, 2023
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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.
| Condition or disease |
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| SARS CoV 2 Infection Multisystem Inflammatory Disease, Pediatric, COVID-19 Related Multisystem Inflammatory Syndrome in Children COVID-19 Pandemic |
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 Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Incidence of Multisystem Inflammatory Syndrome in Children (MIS-C) and Other Complications Following SARS-CoV-2. A Nationwide Population-based Study. |
| Actual Study Start Date : | July 15, 2021 |
| Estimated Primary Completion Date : | July 14, 2024 |
| Estimated Study Completion Date : | December 31, 2024 |
- Incidence of MIS-C, invasive bacterial and viral infections [ Time Frame: August to December 2021 (Delta); December 2021 to unknown (2022) (Omicron) ]
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| Ages Eligible for Study: | 0 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186597
| Contact: Ulrikka Nygaard | 40794656 | Ulrikka@dadlnet.dk |
| Denmark | |
| Copenhagen University Hospital Rigshospitalet | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Ulrikka Nygaard, MD 35453545 ext +45 ulrikka.nygaard@regionh.dk | |
| Responsible Party: | Ulrikka Nygaard, Primary investigator, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT05186597 |
| Other Study ID Numbers: |
H-20028631_MIS-C |
| First Posted: | January 11, 2022 Key Record Dates |
| Last Update Posted: | February 23, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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SARS CoV 2 Infection Multisystem Inflammatory Syndrome in Children COVID-19 Pandemic |
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Infections COVID-19 Syndrome Disease Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |