FAst and SimplE COVID-19 Causing Virus SARS-CoV-2 Detection

COVID-19 Clinical Trial

— FASE2  

Official title:

Innovative Method for the Rapid and Low-cost Search of SARS-CoV-2 in Respiratory Samples: Validation With Multiple Diagnostic Systems and Process Automation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341635
• Other study ID #: FASE2
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2022
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational study using biological material. The group of subjects in the study is represented by 100 male and female patients hospitalized with COVID-19 symptomatology and 100 non-hospitalized subjects with suspected COVID-19 diagnosis for a total of 200 patients.

The expected recruitment time is about 6 months.

Description:

Clinical study using biological material. The group of subjects in the study is represented by 100 male and female patients hospitalized with COVID-19 symptomatology and 100 non-hospitalized subjects with suspected COVID-19 diagnosis for a total of 200 patients.

The expected recruitment time is about 6 months. Each patient will be carried out a nasopharyngeal swab in UTM medium™ which will be tested according to the diagnostic procedure in use, a second nasopharyngeal swab resuspended in MSwab™ and a third oral dry swab that will be transported to the laboratory of Clinical Microbiology and Virology of UNIMIB and resuspersed in the MSwab™ transport medium. The samples will then be treated according to the new workflow defined by the pilot study, i.e. optimization of alternative sample transport systems, in combination with a rapid method of viral RNA extraction, and evaluation of viral inactivation at the end of the extraction phase, by viral culture at the BSL3 laboratory of the Virology laboratory of the University of Milan.

The samples collected and transported on UTM™ medium will be sent to the Microbiology Laboratory of the ASST of Monza and analyzed through the NIMBUS-Seegene platform as per diagnostic routine.

The residual volume of the UTM™ medium sample and all remaining samples taken by each patient will be sent to the Laboratory of Microbiology and Clinical Virology of the University of Milano-Bicocca to be processed through the new preanalytic method in combination with different analytical kits.

A percentage of each sample will be sent to the Virology Laboratory of the University of Milan for testing using the analytical protocol suggested by the CDC.

The study samples will also be used for the validation of a new innovative analytical test for SARS-CoV-2, in Real-Time Multiplex One- Step PCR, developed to be combined with the preanalytic process with thermal extraction, fast and low cost, with high-throughput automation.

All residual volumes of the samples in the study, and related nucleic acids, will be rated and stored in Bio-Bank according to international "standard operating procedures" the validation of further and/or new diagnostic tests for the search for for SARS-CoV-2 (ASST PG23 in collaboration with BBMRI.it).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted to the U.O. of Infectious Diseases of the San Gerardo Hospital in Monza with documented COVID-19 symptomatology;

• COVID-19 asymptomatic or post-hospital discharge;

• People of legal age;

• Patients who agree to participate have given their consent by signing a specially prepared form.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Swab sampling
Collection of three nose-pharyngeal and oral swabs

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Gerardo Monza	Monza	MB

Sponsors (4)

Lead Sponsor	Collaborator
University of Milano Bicocca	A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliera San Gerardo di Monza, University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of a rapid, safe and simplified diagnostic method for the molecular detection and quantification of SARS-CoV-2 in respiratory samples through the set-up of a Real-Time PCR assay expressing results in viral genomic copies/microL of sample	Comparison between the preanalytical procedures commonly used for the processing of the nasopharyngeal swab in the search for SARS-CoV-2 and faster, lower cost and less expensive procedures for the material used as reagents and consumables	Up to three months
Primary	Clinical validation of the performance of the preanalytic method (medium selection and nucleic acids extraction method) in combination with analytical Real-Time PCR assay	Clinical validation of new preanalytical and detection processes, in comparison with different commercial kits in use in Lombardy region laboratories	Through study completation, an average of 6 months
Primary	Development and validation of new preanalytic and analytical methods integrated with high-throughput automation.	Optimization of all the preanalytical and analytical aspects of a diagnostic path for the search of SARS-CoV-2 from different swabs and scale-up of executable samples per day through the implementation of high-throughput processing instrumentation.	Through study completation, an average of 6 months