COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

Coronavirus Infectious Disease 2019 (COVID-19) Clinical Trial

Official title:

COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04625257
• Other study ID #: 2020-01112; ch20Savic2
• Status: Recruiting
• Start date: October 24, 2020
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Miodrag Savic, Dr. med. Dr. med. dent.
• Phone: +41 79 485 31 13
• Email: miodrag.savic[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic patients getting tested for COVID-19

Exclusion Criteria:

• mentally incompetent adults

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infections
• Coronavirus Infectious Disease 2019 (COVID-19)
• COVID-19
• Infections

Intervention

Other:
• Saliva based assay: crude RNA extraction
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 method
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 assays
The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.
• Validation of the POCT Antigen and Antibody tests
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.

Locations

Country	Name	City	State
Switzerland	Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft	Liestal

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	ETH Zurich Department for Biosystems, Science and Engineering, Kanton Basel- Landschaft

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	single point assessment at baseline