COVID-19FASE2NCT05341635
FAst and SimplE COVID-19 Causing Virus SARS-CoV-2 Detection
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Swab sampling
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Swab sampling
- Keywords
- COVID-19, SARS-CoV-2, Molecular, Diagnostic, Test
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swab samplingDiagnostic test
Collection of three nose-pharyngeal and oral swabs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Swab sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Through study completation, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Aug 2020
- Primary completion2 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, University of Milan, A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341635
- Sponsor's protocol ID
- FASE2
- Acronym
- FASE2
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05341635
- Acronym / sponsor ID
- FASE2 / FASE2
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Molecular, Diagnostic, Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, University of Milan, A.O. Ospedale Papa Giovanni XXIII
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Symptomatic inpatients | – | Diagnostic Test: Swab samplingPatients 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. |
| COVID-19 Suspected subjects | – | Diagnostic Test: Swab samplingTo 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swab samplingCollection of three nose-pharyngeal and oral swabs | Diagnostic test | COVID-19 Suspected subjects, COVID-19 Symptomatic inpatients |
Primary outcome
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
Time frame: Up to three months
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
Clinical validation of the performance of the preanalytic method (medium selection and nucleic acids extraction method) in combination with analytical Real-Time PCR assay
Time frame: Through study completation, an average of 6 months
Clinical validation of new preanalytical and detection processes, in comparison with different commercial kits in use in Lombardy region laboratories
Development and validation of new preanalytic and analytical methods integrated with high-throughput automation.
Time frame: Through study completation, an average of 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.