Investigating the COVID-19 mucosal immunity of children in Indonesia
| ISRCTN | ISRCTN32891583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32891583 |
| Secondary identifying numbers | MICIn210920 |
- Submission date
- 01/10/2020
- Registration date
- 02/10/2020
- Last edited
- 01/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
 ORCID ID |
0000-0001-5910-4937 |
|---|---|
| Phone | +62 (0)81325755503 |
| ciptaningtyas_vr@fk.undip.ac.id |
Study information
| Study design | Community-based monocenter prospective cohort exploratory study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Community |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | SARS-CoV-2 mucosal immunity of children in Indonesia (MICIn study) |
| Study acronym | MICIn |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2020 |
| Completion date | 15/10/2021 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | Children aged under 18 |
| Key exclusion criteria | Children without parent/legal guardian permission |
| Date of first enrolment | 15/10/2020 |
| Date of final enrolment | 15/12/2020 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
Sponsor information
University/education
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
| Phone | +62 (0)24 76928010 |
|---|---|
| dean@fk.undip.ac.id | |
| Website | http://www.undip.ac.id/ |
"ROR" |
https://ror.org/056bjta22 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 15/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
01/10/2020: Trial's existence confirmed by the Ethical Committee of Faculty of Medicine Diponegoro University.
