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Clinical features of COVID-19 in Pediatric Patients, long term effects (COPP2-study).

Clinical features of COVID-19 in Pediatric Patients, long term effects (COPP2-study). - COPP-2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55281
Enrollment
120
Registered
2020-08-19
Start date
2020-12-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona SARS-CoV-2

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: Children age 0-17 years, in- or outpatient in Dutch hospitals with a medical history of COVID-19. inclusion in COPP study

Exclusion criteria

Exclusion criteria: - No evidence of COVID-19 - No consent from guardians and/or patient.

Design outcomes

Primary

MeasureTime frame
long-term morbidity, defined as: o Frequency of symptoms, hospital readmission, emergency department or GP visits for symptoms, antibiotic courses for pulmonary infections or start of inhaled corticosteroids and/or b2-mimetics after admission for COVID-19 since diagnosis of COVID-19; o The immunological profile of children at 4-12 months of follow-up after presenting to Dutch hospitals with COVID-19 or MIS-C

Secondary

MeasureTime frame
o Frequency of pulmonary symptoms in the month prior to the follow-up study visit. o Quality of life score in all children and frequency of abnormalities in the neurocognitive profile of patient older than 6 years of age. o Growth. o Frequency of pulmonary function tests abnormalities, including exercise intolerance. o Exhaled breath profiles (SpiroNose/GC-MS). o Frequency and pattern of Chest CT abnormalities in patients with chronic pulmonary complaints and/or pulmonary function abnormalities. o The longevity and quality of the humoral and cellular adaptive immune response in children with a history of COVID-19 or MIS-C. o Complete normalization of hyperinflammatory cytokine profiles in children with COVID-19 or MIS-C after the infection with SARS-CoV-2 o Correlation between the immune response and cytokine profiles to detailed clinical parameters. o Prevalence of olfactory dysfunction at long-term follow-up (4 to 12 months) in previously hospitalized children with COVID-19. o Frequency and risk factors of increased fatigue (according to PROMIS pediatric fatigue) in children with a history of COVID-19 or MIS-C.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)