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COVID-19 PandemicCATKNCT05557513

Research on Community Based ATK Test Study to Control Spread of COVID-19 in Migrant Community

A study testing STANDARD Q COVID-19 Ag Test in people with COVID-19 Pandemic, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thousands of migrants from Myanmar have arrived in Thailand for their safety, better living standards and employment opportunities. They are often in Thailand illegally and have poor access to the Thai health care system. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic
What is being tested?
STANDARD Q COVID-19 Ag Test
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,310 participants
Where
1 siteThailand
Study dates
18 Aug 2022to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult
  1. For Ag RDT arm (primary objective)
  2. Inclusion Criteria
  • *Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family members of COVID-19 patient
  • Participant at any age living in chosen clusters of Maramat and Pohphra Myanmar migrant community
  • Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study.
  1. Exclusion Criteria
  • Known history of a COVID-19 positive test result within the last 21 days
  1. For No Ag RDT arm (primary objective)
  2. Inclusion Criteria
  • Participant at any age living in chosen cluster of Maramat and Pohphra Myanmar migrant community
  • Symptomatic COVID-19 patient/suspected COVID-19 or **close contact/family members of COVID-19 patient who agrees to go for routine Thai COVID-19 ATK or RT-PCR test
  • Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study
  1. Exclusion Criteria
  • Not living in chosen clusters in Maramat and Pohphra Myanmar migrant community note: *Symptomatic or suspected COVID-19: Acute onset of ANY THREE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue1, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting1, diarrhoea, altered mental status (1 Signs separated with slash (/) are to be counted as one sign) Reference: WHO-2019-nCoV-Surveillance_Case_Definition-2020.2-eng (5).pdf note: **1 Person who stayed close to or had conversation with COVID-19 patient(s) for >5 minutes, or was exposed to the patient's cough or sneeze; 2 Individual who stayed in enclosed spaces with poor ventilation together with COVID-19 patient(s) for >30 minutes, for instance, in air-conditioned bus, commuter vane, or air-conditioned room; Reference: g_HCWs_3Mar22.pdf (moph.go.th)
  1. For seroprevalence survey (secondary objective)
  2. Inclusion Criteria
  • Participant at any age living in chosen clusters of Maramat and Pohphra Myanmar migrant community
  • Participant or parent/guardian/caretaker is willing and able to give informed consent for participation in the study.
  1. Exclusion Criteria
  • Refusal to give informed consent, or contraindication to venepuncture
  1. For Focus group discussion (FGD)
  2. Inclusion Criteria
  • Age 18 years and above
  • Living in chosen clusters of Maramat and Pohphra migrant communities
  • Participant is willing and able to give informed consent for participation in the study.
  1. Exclusion Criteria
  • Not living in chosen clusters of Maramat and Pohphra migrant communities

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Shoklo Malaria Research Unit

    Mae Sot, Changwat Tak

Other trials in Thailand

About this study

Official title: Evaluating the Effectiveness and Feasibility of Community Based SARS-CoV-2 Antigen Rapid Diagnostic Testing (Ag-RDT) in the Myanmar Migrant Community, Tak Province Along the Thai Myanmar Border for Controlling Coronavirus Transmission

Thousands of migrants from Myanmar have arrived in Thailand for their safety, better living standards and employment opportunities. They are often in Thailand illegally and have poor access to the Thai health care system. This underutilization not only puts their health at risk but may also put the general public's health at risk. During the COVID-19 pandemic, migrants often have no access to diagnostic tests even though global health actors are focused on accelerating access to COVID-19 testing. SARS-CoV-2 testing is one of the most effective and necessary means of mitigating the COVID-19 pandemic.

The overarching goal of this study is to provide evidence on effectiveness and feasibility of community-based SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) application in the Myanmar migrant community, Tak Province along the Thai Myanmar border as part of test-trace-isolation strategies to fight COVID-19.

After the study has been completed, the study team will have evidence to inform policymakers on whether community based SARS-CoV-2 Ag-RDT test-trace-isolate strategy is effective and feasible to fight COVID-19 where there is limited or no access to COVID-19 testing in the Myanmar migrant communities.

Read the detailed description

This study plan to recruit people who are living in the Maramat and Pohphra Myanmar migrant community or returning to community from outside.

This study includes seroprevalence survey (secondary objective) at the beginning and at the post-intervention of study to estimate the percentage of people in a population who have antibodies against SARS-CoV-2 by capillary blood collection from finger prick. This secondary objective will be achieved through a substudy. In the substudy, 427 participants will be studied from 7 clusters that will be randomly sampled from the parent study for the Ag RDT arm and similarly 427 participants will be studied from 7 clusters that will be randomly sampled from the parent study for the No Ag RDT arm. There will be two cross-sectional surveys in each of these two arms one at baseline and the other at post-intervention. The aim will be to compare the post-intervention percentage of people in a population who have antibodies against SARS-CoV-2 by capillary blood collection from finger prick between the two arms.

The two arms of the substudy will be managed as follows:

One arm (Arm 1): Symptomatic /suspected COVID-19 participant or close contact/family members of COVID-19 patient will be tested with Ag RDT and also involve in awareness-raising campaign with mask distribution.

One arm (Arm 2): No community based Ag RDT testing but there has routine ATK or RT-PCR test by Thai health authorities if local health volunteer finds symptomatic or suspected COVID-19 or close contact with positive cases in their villages. The participant also involves in awareness-raising campaign with mask distribution.

Ten focus group discussion (FGD) with community members will be conducted to find out the attitudes and perception of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community for prevention control of COVID-19 in the study area.

The overarching goal of this study is to provide evidence on effectiveness and feasibility of community-based SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) application in the Myanmar migrant community, Tak Province along the Thai Myanmar border for test-trace-isolation strategies to fight COVID-19.

After the study has been completed, depending upon the study finding, study team believe that study team can propose to policymakers to recognize the effectiveness and feasibility of community-based SARS-CoV-2 Ag-RDT's test-trace-isolate strategies to fight COVID-19 where there is limited or no access to COVID-19 testing in the Myanmar migrant communities

This study was funded by The Foundation for Innovative New Diagnostics (FIND). The grant reference number is U-22008

Being tested
STANDARD Q COVID-19 Ag Test
Keywords
COVID-19, Thailand, ATK, SARS-CoV-2 antigen rapid diagnostic testing
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STANDARD Q COVID-19 Ag TestDevice

    Device Name: STANDARD Q COVID-19 Ag Test Manufactured by SD Biosensor, Inc., Korea

    Purpose: To detect COVID-19 (Its manufacture specification sensitivity was at 84.97% and specificity 98.4%)

Study groups in NCT05557513
Study groupRoleWhat they receive
Ag-RDT (arm 1)Active comparatorSymptomatic /suspected COVID-19 participant or close contact/family members of COVID-19 patient will be tested with Ag RDT and also involve in awareness-raising campaign with mask distribution.
Receives: Device: STANDARD Q COVID-19 Ag Test
No Ag-RDT (arm 2)No interventionNo community based Ag RDT testing but there has routine ATK or RT-PCR test by Thai health authorities if local health volunteer finds symptomatic or suspected COVID-19 or close contact with positive cases in their villages. The participant also involves in awareness-raising campaign with mask distribution.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the differences in number of cases detected per 1,000 people between the Ag-RDT and No Ag-RDT intervention arms.

    The number of cases per 1,000 will be estimated and summarised per group/arm and will compared between groups

    Measured: through study completion, an average of 3 months

Secondary outcomes (3)

  1. Compare the seroprevalence of SAR COV2 antibody between Ag-RDT Arm (1) and No Ag-RDT Arm (2)

    Seroprevalence of SAR COV2 antibody in each of the groups at baseline and at post-intervention surveys.

    Measured: through study completion, an average of 3 months

  2. Find out about the attitudes of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community

    Attitudes of community participants towards community base SAR COV2 Ag-RDTs use.

    Measured: through study completion, an average of 3 months

  3. Find out about the perception of community members on the use of community based SAR COV2 Ag-RDTs testing in Myanmar migrant community

    Perception of community participants towards community base SAR COV2 Ag-RDTs use.

    Measured: through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start18 Aug 2022
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
For primary objective (Ag-RDT (arm 1) and no Ag-RDT (arm 2)) 74 clusters (37 in each arm) Approximate 5,500 participants in arm 1 and 5,500 participants in arm 2
Masking
None (open label)
Enrolment
1,310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557513
Sponsor's protocol ID
VIR22002
Acronym
CATK
Status last verified
Apr 2024
First submitted
15 Jun 2022
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collected for this study will be under the custodianship of MORU, will be de-identified and may be shared in fully anonymised form with other researchers in accordance with the current Data Sharing Policy. (https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs ).

Questions about this trial

What is this clinical trial studying?

A study testing STANDARD Q COVID-19 Ag Test in people with COVID-19 Pandemic, run by University of Oxford at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the differences in number of cases detected per 1,000 people between the Ag-RDT and No Ag-RDT intervention arms. (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557513.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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