ISRCTN - ISRCTN32891583: Investigating the COVID-19 mucosal immunity of children in Indonesia

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
The SARS-CoV-2 pandemic has had a profound effect on the lives of all people. Children are a group that gets a lot of attention due to the possibility of subclinical infection and virus transmission. More in-depth knowledge is needed about the development of mucosal immunity (the immune system associated with mucosal sites such as the gut). The aim of this study is to Investigate the COVID-19 mucosal immunity of children in Indonesia.

Who can participate?
Children aged under 18

What does the study involve?
Mucosal lining fluid will be taken from participants' noses using sterile filter paper to identify mucosal antibodies towards the SARS-CoV-2 virus. The sample will be collected three times on days 0, 14, and 28. The researchers will also take a medical history from the participants/parents/carers and physically examine the children.

What are the possible benefits and risks of participating?
There is no risk or benefit from participating.

Where is the study run from?
Diponegoro University (Indonesia)

When is the study starting, and how long is it expected to run for?
May 2020 to October 2021

Who is funding the study?
Diponegoro University (Indonesia)

Who is the main contact?
Dr Vincentia Rizke Ciptaningtyas
ciptaningtyas_vr@fk.undip.ac.id

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Vincentia Rizke Ciptaningtyas

ORCID ID

http://orcid.org/0000-0001-5910-4937

Contact details

Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
+62 (0)81325755503
ciptaningtyas_vr@fk.undip.ac.id

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MICIn210920

Study information

Scientific title

SARS-CoV-2 mucosal immunity of children in Indonesia (MICIn study)

Acronym

MICIn

Study hypothesis

The SARS-CoV-2 pandemic has had a profound effect on the lives of all people. Children are a group that gets a lot of attention related to the possibility of subclinical infection, and also the possibility of them transmitting the virus. More in-depth knowledge is needed about the development of mucosal immunity.

Ethics approval

Approved 31/08/2020, Diponegoro University Faculty of Medicine Health Research Ethics Committee (Kantor Dekanat Lama FK Undip lt.1, Jl. Dr. Soetomo 18, Semarang, Indonesia; +62 (0)24 769280010 ext 7820; komisietik@gmail.com), ref: 211/EC/KEPK/FK UNDIP/VIII/2020

Study design

Community-based monocenter prospective cohort exploratory study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

All participants will receive the three-time intervention after they have given their consent/assent. The researchers will take a medical history from participants/parents/carer and physically examine the children. Mucosal lining fluid will be collected using sterile filter paper in the nasal cavity to identify mucosal antibodies towards SARS-CoV-2. The sample will be collected three times on days 0, 14, and 28.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Mucosal immunity of SARS-COV-2 measured using fluorescent-bead-based multiplex immunoassay at baseline, 14 and 28 days

Secondary outcome measures

Disease symptoms measured using physical examination and anamnesis (COVID-19-related symptoms 14 days before sample collection, contact history, and comorbidities), recorded at baseline, 14, and 28 days.

Overall trial start date

01/05/2020

Overall trial end date

15/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Children aged under 18

Participant type

All

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

Children without parent/legal guardian permission

Recruitment start date

15/10/2020

Recruitment end date

15/12/2020

Locations

Countries of recruitment

Indonesia

Trial participating centre

Diponegoro University
Jl. Prof. Soedarto SH Kelurahan Tembalang Kecamatan Tembalang
Semarang
50275
Indonesia

Sponsor information

Organisation

Diponegoro University

Sponsor type

University/education

Website

http://www.undip.ac.id/

Funders

Funder type