Covid19NCT04974203
Saliva-based COVID-19 DNA Aptamer Test
A study testing AptameX in people with Covid19, run by Achiko AG at 1 site in Indonesia.
Trial summary
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Covid19
- What is being tested?
- AptameX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2021to Aug 2021
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-59 years old
- Undertaking PCR swab test for screening, or
- In-patients undertaking PCR swab test
Who cannot join
- Unable to produce saliva
- Refusing to participate
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Udayana University Hospital
Badung, Bali, 80361
I Md A Wirawan, MD, PhD, 081239394465, ady.wirawan@unud.ac.id
I Md Ady Wirawan, MD, Ph.D
About this study
Official title: Saliva-based COVID-19 DNA Aptamer Test: Formative Usability and Internal Validation Study
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's PCR test results.
Read the detailed description
RT-PCR has several limitations that need to be considered in its role as a COVID-19 diagnostic modality, especially in areas with limited health infrastructure. Potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. The DNA Aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva.
The development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. This study aims to conduct formative usability and internal validation of the DNA aptamer-based COVID-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's PCR test data.
- Conditions
- Covid19
- Being tested
- AptameX
- Keywords
- Saliva-based test, DNA aptamer
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AptameXDevice
DNA aptamer-based test using patient's saliva
| Study group | Role | What they receive |
|---|---|---|
| CT Value <25 | Experimental | Patients with CT value <25 Receives: Device: AptameX |
| CT Value 25+ | Experimental | Patients with CT value of 25 or higher Receives: Device: AptameX |
| Negative | Experimental | Patients with negative PCR test result Receives: Device: AptameX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hands-On-Time (HOT)
Total time (seconds) spent by the Operator(s) to process one test
Measured: 1 month
Time-To-Result (TTR)
Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative
Measured: 1 month
Testing Centre First-Time-Hit percentage (FTH)
The FTH percentage measures proportion of test kits that will be correctly processed with no single mistake, from the opening of the test kit to recording the test result.
Measured: 1 month
Technician Subjective elements
Aspects of the workflow liked/not liked by the technicians
Measured: 1 month
Patient subjective elements
Aspects of the workflow liked/not liked by the patient during saliva collection
Measured: 1 month
Secondary outcomes (4)
Sensitivity
The ability of a test to correctly identify those with the disease (true positive rate)
Measured: 1 month
Specificity
The ability of the test to correctly identify those without the disease (true negative rate)
Measured: 1 month
Positive Predictive Value
The proportions of positive results that are true positive results
Measured: 1 month
Negative Predictive Value
The proportions of negative results that are true negative results
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients who undertake PCR test are asked to provide saliva sample
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Achiko AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Udayana University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974203
- Sponsor's protocol ID
- 2021.03.3.0102
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be managed by investigators only. Analyzed data or result summary will be shared to related researchers or other parties
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva-based COVID-19 DNA Aptamer Test: Formative Usability and Internal Validation Study
- ClinicalTrials.gov ID
- NCT04974203
- Acronym / sponsor ID
- 2021.03.3.0102
- Conditions
- Covid19
- Keywords
- Saliva-based test, DNA aptamer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Achiko AGIndustry (pharma, biotech, devices)
- Collaborators
- Udayana University
- Study start
- Jul 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's PCR test results.
Detailed description
RT-PCR has several limitations that need to be considered in its role as a COVID-19 diagnostic modality, especially in areas with limited health infrastructure. Potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. The DNA Aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva.
The development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. This study aims to conduct formative usability and internal validation of the DNA aptamer-based COVID-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's PCR test data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Patients who undertake PCR test are asked to provide saliva sample
| Arm | Type | Receives |
|---|---|---|
| CT Value <25 | Experimental | Device: AptameXPatients with CT value <25 |
| CT Value 25+ | Experimental | Device: AptameXPatients with CT value of 25 or higher |
| Negative | Experimental | Device: AptameXPatients with negative PCR test result |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-59 years old
- Undertaking PCR swab test for screening, or
- In-patients undertaking PCR swab test
Key exclusion criteria (2 listed)
- Unable to produce saliva
- Refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AptameXDNA aptamer-based test using patient's saliva | Device | CT Value 25+, CT Value <25, Negative |
Primary outcome
Hands-On-Time (HOT)
Time frame: 1 month
Total time (seconds) spent by the Operator(s) to process one test
Time-To-Result (TTR)
Time frame: 1 month
Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative
Testing Centre First-Time-Hit percentage (FTH)
Time frame: 1 month
The FTH percentage measures proportion of test kits that will be correctly processed with no single mistake, from the opening of the test kit to recording the test result.
Technician Subjective elements
Time frame: 1 month
Aspects of the workflow liked/not liked by the technicians
Patient subjective elements
Time frame: 1 month
Aspects of the workflow liked/not liked by the patient during saliva collection
4 secondary outcomes
Sensitivity
Time frame: 1 month
Specificity
Time frame: 1 month
Positive Predictive Value
Time frame: 1 month
Negative Predictive Value
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No. Individual participant data will be managed by investigators only. Analyzed data or result summary will be shared to related researchers or other parties
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AptameX in people with Covid19, run by Achiko AG at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hands-On-Time (HOT) (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2021.