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Severe SARS-COV-2 (COVID-19) related disease in low and middle income country children aged 0-19 years: a multicountry cohort study in a network of hospitals

Severe SARS-COV-2 (COVID-19) related disease in low and middle income country children aged 0-19 years: a multicountry cohort study in a network of hospitals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001154897
Enrollment
3000
Registered
2021-08-26
Start date
2020-01-01
Completion date
2021-12-31
Last updated
2022-10-31

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

Conditions

None listed

Brief summary

Severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) related disease in childhood includes both acute COVID-19 disease and multisystem inflammatory syndrome in children (MIS-C). There is very little information about acute COVID-19 disease and MIS-C in children presenting to hospital in low- and middle-income countries (LMICs). Our overall aim is to understand the clinical characteristics of SARS-CoV-2 related disease in neonates, children and adolescents aged 0-19 years hospitalised with COVID-19 or MIS-C in LMICs. Our objectives are to use hospital network surveillance systems in four LMICs to: (i) describe clinical presentations, comorbidities, diagnostic and laboratory features, currently available therapies, hospital outcomes and medium-term outcomes; and (ii) describe the association between SARS-CoV-2 related disease severity and underlying comorbidities. This is a cohort surveillance study with retrospective and prospective components. Children aged 0-19 years presenting to hospital with any new illness since 1 January 2020 who have evidence of SARS-CoV-2 exposure or infection are eligible to be part of the study. Recruitment will extend until December 2021 and children will be followed for three months to ascertain sequelae data. Key activities are; (i) data collection via extraction of data from hospital medical records and during monthly telephonic or face-to-face interviews with the parent or guardian (ii) data analysis ; and (iii) reporting. To our knowledge this is one of the first longitudinal multicountry cohort studies of severe COVID-19 and MIS-C in LMICs. Results will be disseminated at country and regional levels and will be used to improve clinical practice guidelines and protocols in collaboration with the network hospitals in all countries.

Interventions

The primary exposure is undernutrition as defined by the country sites. Secondary exposures are overnutrition as defined by the country sites, other concurrent infection as defined by the country sites. All exposures can be identified during any hospital admission of a child aged 0-19 years from January 2020 to December 2021. Retrospective data will be collected from January 2020 to March 2021. Prospective data will be collected from March 2021 to December 2021.

Sponsors

World Health Organization, Department of Maternal and Child Health
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
0 to 19 Years
Healthy volunteers
No

Inclusion criteria

Any child aged 0-19 years admitted to hospital who has either (i) exposure to SARS-CoV2 infection or (ii) confirmed SARS-CoV2 infection.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026