FAst and SimplE COVID-19 Causing Virus SARS-CoV-2 Detection (FASE2)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Swab sampling

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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • Azienda Ospedaliera San Gerardo Monza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 Symptomatic inpatients; Patients admitted to the Unit of Infectious Diseases of the ASST Monza for COVID-19 will run the collection of a nasopharyngeal swab, performed as part of the normal diagnostic routine; will take up to two samples collected in parallel to the development and optimization of the new method/process preanalitico and for the clinical validation of the performance of the pre-analytic method. The subjects will be adequately informed, both verbally and by means of a summary document of the study before signing a consent for participation in the study.	Diagnostic test: Swab sampling; Collection of three nose-pharyngeal and oral swabs
COVID-19 Suspected subjects; To the subjects who present at the Emergency department of the ASST Monza for symptomatology referable to the COVID-19 and to patients on discharge from the Unit of Infectious Diseases of the ASST Monza for complete healing from COVID-19 will run the collection of a nasopharyngeal swab, performed as part of the normal diagnostic routine; will take up to two samples collected in parallel to the development and optimization of the new method/process preanalitico and for the clinical validation of the performance of the pre-analytic method. The subjects will be adequately informed, both verbally and by means of a summary document of the study before signing a consent for participation in the study.	Diagnostic test: Swab sampling; Collection of three nose-pharyngeal and oral swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: University of Milan; A.O. Ospedale Papa Giovanni XXIII; Azienda Ospedaliera San Gerardo di Monza

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Diagnostic; Molecular; Test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FASE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No