Coronavirus Infectious Disease 2019 (COVID-19)NCT04625257
COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)
An observational study of Coronavirus Infectious Disease 2019 (COVID-19), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infectious Disease 2019 (COVID-19)
- What is being tested?
- Saliva based assay: crude RNA extraction, Validation of the NGS method and Validation of the LAMP assays
- How many people
- 1,600 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Oct 2020to Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients arriving at the COVID-19 test center Feldreben in Muttenz, Basel Land and at Swiss TPH in Basel, Basel Stadt to get tested for COVID-19.
Who may be able to join
- symptomatic patients getting tested for COVID-19
Who cannot join
- mentally incompetent adults
Trial locations and contacts
1 site in 1 country.
Juerg Sommer, Dr. contact
Switzerland1 site, 1 recruiting
- Recruiting
Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
Liestal, 4410
Miodrag Savic, Dr. med. Dr. med. dent., +41 79 485 31 13, miodrag.savic@usb.ch
About this study
This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.
- Being tested
- Saliva based assay: crude RNA extraction, Validation of the NGS method, Validation of the LAMP assays, Validation of the POCT Antigen and Antibody tests
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay, point of care tests (POCT), next-generation sequencing (NGS) method, contact tracing, transmission chains, crude RNA extraction from saliva, loop mediated amplification (LAMP) assay, viral nucleic acid analysis platform
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva based assay: crude RNA extractionOther
Crude RNA extraction to inactivate the virus and stabilize the RNA for transport at room temperature. Validation of the crude RNA extraction from saliva in combination with NGS diagnostics and LAMP assays and point of care test (POCT) for rapid detection of viral antigens on patients' samples.
Validation of the NGS methodOther
Compare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab.
Validation of the LAMP assaysOther
The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.
Validation of the POCT Antigen and Antibody testsOther
Rapid point of care tests (POCT) detecting viral protein antigens (Ag) and antibodies (Ab) on patients' samples. POCT are often employed in low income countries, but for COVID-19 they are not yet characterized. Their performance is to be characterized that they can be used as a safe guard if the lab diagnostics fail.
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)
For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared.
Measured: single point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start24 Oct 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Infectious Disease 2019 (COVID-19)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich Department for Biosystems, Science and Engineering, Kanton Basel- Landschaft
- Responsible party
- Sponsor
- Investigators
- Miodrag Savic, Dr. med. Dr. med. dent., Principal investigator, Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625257
- Sponsor's protocol ID
- 2020-01112; ch20Savic2
- Status last verified
- Feb 2024
- First submitted
- 10 Nov 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)
- ClinicalTrials.gov ID
- NCT04625257
- Acronym / sponsor ID
- 2020-01112; ch20Savic2
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay, point of care tests (POCT), next-generation sequencing (NGS) method, contact tracing, transmission chains, crude RNA extraction from saliva, loop mediated amplification (LAMP) assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- ETH Zurich Department for Biosystems, Science and Engineering, Kanton Basel- Landschaft
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Nov 2020 (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 is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients arriving at the COVID-19 test center Feldreben in Muttenz, Basel Land and at Swiss TPH in Basel, Basel Stadt to get tested for COVID-19.
Key inclusion criteria (1 listed)
- symptomatic patients getting tested for COVID-19
Key exclusion criteria (1 listed)
- mentally incompetent adults
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 |
|---|---|---|
| Saliva based assay: crude RNA extractionCrude RNA extraction to inactivate the virus and stabilize the RNA for transport at room temperature. Validation of the crude RNA extraction from saliva in combination with NGS diagnostics and LAMP assays and point of care test (POCT) for rapid detection of viral antigens on patients' samples. | Other | – |
| Validation of the NGS methodCompare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab. | Other | – |
| Validation of the LAMP assaysThe RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay. | Other | – |
| Validation of the POCT Antigen and Antibody testsRapid point of care tests (POCT) detecting viral protein antigens (Ag) and antibodies (Ab) on patients' samples. POCT are often employed in low income countries, but for COVID-19 they are not yet characterized. Their performance is to be characterized that they can be used as a safe guard if the lab diagnostics fail. | Other | – |
Primary outcome
qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)
Time frame: single point assessment at baseline
For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
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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.
Juerg Sommer, Dr. contact
Miodrag Savic, Dr. med. Dr. med. dent. principal investigator
Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infectious Disease 2019 (COVID-19), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 Feb 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 Switzerland. 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?
Contact Miodrag Savic, Dr. med. Dr. med. dent. (+41 79 485 31 13, miodrag.savic@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection) (time frame: single point assessment at baseline). 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 Feb 2024.