ANZCTR - Registration

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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]

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

COVID-19

Malnutrition

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

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]

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]

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]

During any hospital admission in a child aged 0-19 years from January 2020 to December 2021.

Secondary outcome [1]

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]

At 3 months follow up

Secondary outcome [2]

Death

Timepoint [2]

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?

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]

Ethiopia

State/province [1]

Country [2]

India

State/province [2]

Country [3]

Pakistan

State/province [3]

Country [4]

South Africa

State/province [4]

Funding & Sponsors

Funding source category [1]

Other

Name [1]

World Health Organization, Science Division

Address [1]

World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

World Health Organization, Geneva

Ethics committee address [1]

World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

Approval date [1]

31/12/2020

Ethics approval number [1]

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

Dr Karen Edmond

Address

World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland

Country

Switzerland

Phone

+41 22 791 21 11

Fax

[email protected]

Contact person for public queries

Name

Karen Edmond

Address

World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland

Country

Switzerland

Phone

+41227912111

Fax

[email protected]

Contact person for scientific queries

Name

Karen Edmond

Address

World Health Organization, 20 Avenue Appia, Geneva, 1211, Switzerland

Country

Switzerland

Phone

+41227912111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Data are owned by individual country sites

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12776	Study protocol	Will 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.

Trial Review

Documents added manually

Documents added automatically