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 details
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
+62 (0)24 76928010
dean@fk.undip.ac.id
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Diponegoro University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The findings from this research study will be published in an appropriate scientific journal (and made available open access) and/or presented at an appropriate meeting.
IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
15/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list