Clinical trial NCT05341635: FAst and SimplE COVID-19 Causing Virus SARS-CoV-2 Detection
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Molecular
Diagnostic
Test
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera San Gerardo di Monza
name: University of Milan
name: A.O. Ospedale Papa Giovanni XXIII
First posted: 2022-04-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The group of study subjects is represented by 100 men and women patients hospitalized with COVID-19 symptoms and 100 non-hospitalized subjects with suspected COVID-19 diagnosis for a total of 200 patients.

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to three months
measure: Clinical validation of the performance of the preanalytic method (medium selection and nucleic acids extraction method) in combination with analytical Real-Time PCR assay
timeFrame: Through study completation, an average of 6 months
measure: Development and validation of new preanalytic and analytical methods integrated with high-throughput automation.
timeFrame: Through study completation, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo Monza
state: MB
Study officials:
References: