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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047900
• Other study ID #: COA. MURA2021/711
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: January 13, 2023

Study information

• Verified date: January 2023
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70000
• Est. completion date: January 13, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Covid19
• SARS-CoV-2

Intervention

Diagnostic Test:
• Rapid antigen testing kit
COVID-19 Saliva Antigen Rapid Test Tigsun COVID-19 Speichel Antigen-Schnelltest

Locations

Country	Name	City	State
Thailand	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

Sponsors (5)

Lead Sponsor	Collaborator
Mahidol University	Chulalongkorn University, Ministry of Health, Thailand, Yuvabadhana foundation, Zero COVID Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of COVID19 infection	Incidence rate of COVID19 infection in intervention group and control group	3 week
Secondary	Incidence rate of severe COVID19 infection	severe COVID19 infection defined as ICU admission, on mechanical ventilator in intervention group and control group	3 week
Secondary	Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people		3 week
Secondary	sensitivity and specificity of rapid antigen testing kit	compare with standard PCR	3 week