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

NCT05047900 | Completed DMC

• 1 other identifier: COA. MURA2021/711
• Study Type: interventional
• Target: 70,000
• Locations: 1 country
• Sites: 6

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. 1.To compare the incidence of severe COVID-19 between communities with rapid antigen tests and without rapid antigen tests.
2. 2.To study the decrease in incidence of community-acquired COVID-19 in communities with rapid antigen tests.
3. 3.To study factors affecting community-acquired COVID-19 in these communities.
4. 4.To campaign for the government to recognize the importance and effectiveness of weekly testing, and propose suitable strategies to fight COVID.

Conditions

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

Keywords

ATK; Covid19; Rapid antigen testing kit; Screening; Community transmissions; SARS-CoV-2; Coronavirus; Infectious diseases

Outcome Measures

Primary Outcomes (1)

• Incidence rate of COVID19 infection

  Incidence rate of COVID19 infection in intervention group and control group

  3 week

Secondary Outcomes (3)

• Incidence rate of severe COVID19 infection

  3 week

• Incidence of COVID19 infection in COVID19 vaccinated and non vaccinated people

  3 week

• sensitivity and specificity of rapid antigen testing kit

  3 week

Study Arms (3)

Rapid antigen testing kit use once weekly

EXPERIMENTAL

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

Diagnostic Test: Rapid antigen testing kit

Rapid antigen testing kit use twice weekly

EXPERIMENTAL

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

Diagnostic Test: Rapid antigen testing kit

Control

NO INTERVENTION

Did not routinely use Rapid antigen testing kit

Interventions

Rapid antigen testing kit DIAGNOSTIC_TEST

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

Rapid antigen testing kit use once weekly; Rapid antigen testing kit use twice weekly

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Mahidol University: lead
• Yuvabadhana foundation: collaborator
• Zero COVID Thailand: collaborator
• Chulalongkorn University: collaborator
• Ministry of Health, Thailand: collaborator

Study Sites (6)

Provincial Community Housing Complex

Bangkok, 10330, Thailand

Location

Rural Community

Chiang Mai, Thailand

Location

Rural Community

Chiang Rai, Thailand

Location

Rural Community

Mae Hong Son, Thailand

Location

Rural Community

Phang Nga, Thailand

Location

Rural Community

Ranong, Thailand

Location

Related Publications (5)

• 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.

  PMID: 32692208 BACKGROUND

• 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.

  PMID: 33758017 BACKGROUND

• 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.

  PMID: 32800855 BACKGROUND

• 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.

  PMID: 32585619 BACKGROUND

• 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.

  PMID: 33309541 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gasit Saksirisampant, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Dhammika Leshan Wannigama, MD.PhD

  Chulalongkorn University

  STUDY CHAIR

• Katika Akksilp, MD

  Ministry of Health, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 17, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: January 13, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (6)