The Impact of SARS-CoV-2 Rapid Antigen Testing Kit Screening in Bangkok Community

NCT ID: NCT05047900

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-01-13

Brief Summary

Our current focus is to reduce the spread of COVID through distribution of Rapid Antigen Test Kits (ATKs) to low-income, high-risk communities across Bangkok.

Hospitals across Thailand have been operating over capacity for many months, both in receiving the high number of cases as well as in testing for COVID. RT PCR, although highly sensitive, requires potentially infectious people to travel to testing sites, wait in line, and takes 1-2 days to return results, leading to further spread of COVID through increased contact with other high-risk individuals.

On the contrary, testing via an Antigen Test Kit (ATK) can be done by everyone at home with the potential to test more frequently than the PCR test due to much cheaper cost. This means that ATK testing can be mixed into people's daily lifestyle, but another underlying reason is that ATKs only show test results as positive only when an infected person is contagious. Another key advantage is the rapid results, which helps people identify risks quickly, limiting spread even faster.

Our trial therefore aims to achieve the following primary objective:

To monitor the results of freely distribute ATKs in real environments to measure its effectiveness in reducing COVID spread in communities by comparing the incidence of COVID-19 between communities with rapid antigen tests and without rapid antigen tests.

Secondary objectives are:

1. To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests.

2. To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests.

3. To study factors affecting community-acquired COVID-19 in these communities.

4. To campaign for the government to recognize the importance and effectiveness of weekly testing, and propose suitable strategies to fight COVID.

Detailed Description

The cluster randomized controlled trial will be conducted in Bangkok communities supported by Thaicare. A total number of 70,000 participants will be enrolled from 70 clusters. (1,000 from each cluster). Participants from each area will be divided into three groups according to the accommodation type. The rational between intervention group 1 to intervention group 2 and control group will be 1:1:1. The characteristics of population in each stratum will be reproduced as closely as possible. Cluster randomization by software will be used to blind the order of randomization. Demographic data (i.e., age, gender, weight, height, body mass index), concomitant diseases, income, type of accommodation, vaccination profile) of the control and intervention groups will be collected. The collection of data and the obtaining of the consent will be conducted by Socialgiver volunteers. There will be 2 intervention groups. Group 1 will receive 4 rapid antigen kits at the beginning of the study and will be asked to conduct a weekly self-test for 3 weeks. Group 2 will receive 7 rapid antigen kits at the beginning of the study and will be asked to conduct a twice-weekly self-test for 3 weeks (total of 6 tests)

Conditions

Covid19; SARS-CoV-2; Community Transmissions; Coronavirus Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Rapid antigen testing kit use once weekly

Community will use rapid antigen testing kit once weekly every Monday and will be asked to conduct a weekly self-test for 3 weeks.

This research use COVID-19 Saliva Antigen Rapid Test from Tigsun COVID-19 Speichel Antigen-Schnelltest from Beijing Tigsun Diagnostics

Group Type: EXPERIMENTAL

Rapid antigen testing kit

Intervention Type: DIAGNOSTIC_TEST

COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Rapid antigen testing kit use twice weekly

Community will use rapid antigen testing kit twice weekly every Monday and Thursday and will be asked to conduct a twice-weekly self-test for 3 weeks This research use COVID-19 Saliva Antigen Rapid Test from Tigsun COVID-19 Speichel Antigen-Schnelltest from Beijing Tigsun Diagnostics

Group Type: EXPERIMENTAL

Rapid antigen testing kit

Intervention Type: DIAGNOSTIC_TEST

COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Control

Did not routinely use Rapid antigen testing kit

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rapid antigen testing kit

COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Inclusion criteria (community level): every Bangkok community under Thai Care. Exclusion criteria (community level): any Bangkok community in which the community coordinator cannot participate in the study.

Inclusion criteria (individual level): anyone who are over 10 years old. Exclusion criteria (individual level): anyone who are not consent or unable to give consents. Those who are known to be COVID-19 positive or currently treated with favipiravir

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuvabadhana foundation

UNKNOWN

Sponsor Role: collaborator

Zero COVID Thailand

UNKNOWN

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Gasit Saksirisampant

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gasit Saksirisampant, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Dhammika Leshan Wannigama, MD.PhD

Role: STUDY_CHAIR

Chulalongkorn University

Katika Akksilp, MD

Role: STUDY_DIRECTOR

Ministry of Health, Thailand

Locations

Provincial Community Housing Complex

Bangkok, , Thailand

Rural Community

Chiang Mai, , Thailand

Rural Community

Chiang Rai, , Thailand

Rural Community

Mae Hong Son, , Thailand

Rural Community

Phang Nga, , Thailand

Rural Community

Ranong, , Thailand

Countries

Thailand

References

Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. Ann Palliat Med. 2020 Jul;9(4):1404-1412. doi: 10.21037/apm-20-887. Epub 2020 Jul 13.

Reference Type: BACKGROUND

PMID: 32692208 (View on PubMed)

Pavelka M, Van-Zandvoort K, Abbott S, Sherratt K, Majdan M; CMMID COVID-19 working group; Institut Zdravotnych Analyz; Jarcuska P, Krajci M, Flasche S, Funk S. The impact of population-wide rapid antigen testing on SARS-CoV-2 prevalence in Slovakia. Science. 2021 May 7;372(6542):635-641. doi: 10.1126/science.abf9648. Epub 2021 Mar 23.

Reference Type: BACKGROUND

PMID: 33758017 (View on PubMed)

Hirotsu Y, Maejima M, Shibusawa M, Nagakubo Y, Hosaka K, Amemiya K, Sueki H, Hayakawa M, Mochizuki H, Tsutsui T, Kakizaki Y, Miyashita Y, Yagi S, Kojima S, Omata M. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis. 2020 Oct;99:397-402. doi: 10.1016/j.ijid.2020.08.029. Epub 2020 Aug 12.

Reference Type: BACKGROUND

PMID: 32800855 (View on PubMed)

Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET, Chan RC, Tsang DN. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020 Aug;129:104500. doi: 10.1016/j.jcv.2020.104500. Epub 2020 Jun 8.

Reference Type: BACKGROUND

PMID: 32585619 (View on PubMed)

Agullo V, Fernandez-Gonzalez M, Ortiz de la Tabla V, Gonzalo-Jimenez N, Garcia JA, Masia M, Gutierrez F. Evaluation of the rapid antigen test Panbio COVID-19 in saliva and nasal swabs in a population-based point-of-care study. J Infect. 2021 May;82(5):186-230. doi: 10.1016/j.jinf.2020.12.007. Epub 2020 Dec 9. No abstract available.

Reference Type: BACKGROUND

PMID: 33309541 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COA. MURA2021/711

Identifier Type: -

Identifier Source: org_study_id