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

NCT ID: NCT05341635

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-30

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).

Conditions

COVID-19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Swab sampling

Intervention Type: DIAGNOSTIC_TEST

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.

Swab sampling

Intervention Type: DIAGNOSTIC_TEST

Collection of three nose-pharyngeal and oral swabs

Interventions

Swab sampling

Collection of three nose-pharyngeal and oral swabs

Intervention Type: DIAGNOSTIC_TEST

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role: collaborator

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliera San Gerardo Monza

Monza, MB, Italy

Countries

Italy

Other Identifiers

FASE2

Identifier Type: -

Identifier Source: org_study_id