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

NCT05341635 | Completed

• 1 other identifier: FASE2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Molecular; Diagnostic; Test

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Swab sampling DIAGNOSTIC_TEST

Collection of three nose-pharyngeal and oral swabs

COVID-19 Suspected subjects; COVID-19 Symptomatic inpatients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

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

Study Sites (1)

Azienda Ospedaliera San Gerardo Monza

Monza, MB, 20900, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal and saliva specimen

MeSH Terms

Conditions

COVID-19; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 22, 2022
• Study Start: August 1, 2020
• Primary Completion: December 2, 2020
• Study Completion: December 30, 2020
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

IT (1)