Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001154897
Ethics application status
Approved
Date submitted
6/08/2021
Date registered
26/08/2021
Date last updated
24/10/2022
Date data sharing statement initially provided
26/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 304978 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe SARS-COV-2 related disease 323129 0
COVID-19 323374 0
Malnutrition 323375 0
Condition category
Condition code
Respiratory 320704 320704 0 0
Other respiratory disorders / diseases
Infection 320948 320948 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 321369 0
Not applicable
Comparator / control treatment
The comparator group is all children aged 0-19 years without the primary or secondary exposures as defined above.
Control group
Active

Outcomes
Primary outcome [1] 328520 0
Severe SARS-CoV-2 related disease in children aged 0-19 years as ascertained from either hospital records or through a telephone or in person interview.
Timepoint [1] 328520 0
During any hospital admission in a child aged 0-19 years from January 2020 to December 2021.
Secondary outcome [1] 399318 0
Any sequelae in children aged 0-19 years. This is an exploratory outcome. It will be ascertained from either hospital records or through a telephone or in person interview.
Timepoint [1] 399318 0
At 3 months follow up
Secondary outcome [2] 399891 0
Death
Timepoint [2] 399891 0
Any time during hospital admission up to 3 months post discharge

Eligibility
Key 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.
Minimum age
0 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Multivariable logistic and linear regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
30/09/2021
Actual
31/12/2021
Date of last data collection
Anticipated
31/12/2021
Actual
31/12/2021
Sample size
Target
2100
Accrual to date
Final
3000
Recruitment outside Australia
Country [1] 24028 0
Ethiopia
State/province [1] 24028 0
Country [2] 24029 0
India
State/province [2] 24029 0
Country [3] 24030 0
Pakistan
State/province [3] 24030 0
Country [4] 24031 0
South Africa
State/province [4] 24031 0

Funding & Sponsors
Funding source category [1] 309365 0
Other
Name [1] 309365 0
World Health Organization, Science Division
Country [1] 309365 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization, Department of Maternal and Child Health
Address
World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland
Country
Switzerland
Secondary sponsor category [1] 310337 0
None
Name [1] 310337 0
Address [1] 310337 0
Country [1] 310337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309182 0
World Health Organization, Geneva
Ethics committee address [1] 309182 0
World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland
Ethics committee country [1] 309182 0
Switzerland
Date submitted for ethics approval [1] 309182 0
Approval date [1] 309182 0
31/12/2020
Ethics approval number [1] 309182 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113258 0
Dr Karen Edmond
Address 113258 0
World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland
Country 113258 0
Switzerland
Phone 113258 0
+41 22 791 21 11
Fax 113258 0
Email 113258 0
[email protected]
Contact person for public queries
Name 113259 0
Karen Edmond
Address 113259 0
World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland
Country 113259 0
Switzerland
Phone 113259 0
+41227912111
Fax 113259 0
Email 113259 0
[email protected]
Contact person for scientific queries
Name 113260 0
Karen Edmond
Address 113260 0
World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland
Country 113260 0
Switzerland
Phone 113260 0
+41227912111
Fax 113260 0
Email 113260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data are owned by individual country sites


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12776Study protocolWill be published in open access journal, is in preparation   



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.