Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
122 participants
INTERVENTIONAL
2020-04-16
2020-07-31
Brief Summary
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The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.
The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.
Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.
The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Symptomatic patients
Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.
rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
Asymptomatic subjects
Asymptomatic patients with low risk phenotype, that means patients with a previous negative swab, no relatives affected by COVID-19 and with reduced social interaction within the last two weeks.
rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
Interventions
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rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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Università degli Studi dell'Insubria
OTHER
Responsible Party
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Lorenzo Azzi
Assistant Professor
Principal Investigators
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Lorenzo Azzi
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi dell'Insubria
Locations
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ASST dei Sette Laghi
Varese, VA, Italy
Countries
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Other Identifiers
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68/2020
Identifier Type: -
Identifier Source: org_study_id