Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19)

NCT04357327 | Completed

• 1 other identifier: 68/2020
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. 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).

Conditions

COVID-19; SARS-CoV 2; Corona Virus Infection

Keywords

SARS-CoV-2; COVID-19; Saliva; nCoV-2019; Coronavirus

Outcome Measures

Primary Outcomes (2)

• Sensibility

  TP/TP+FN (TP= True Positive; FN = False Negative)

  Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.

• Specificity

  TN/TN+FP (TN= True Negative; FP= False Positive)

  Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.

Study Arms (2)

Symptomatic patients

EXPERIMENTAL

Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.

Diagnostic Test: rapid salivary test

Asymptomatic subjects

ACTIVE COMPARATOR

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.

Diagnostic Test: rapid salivary test

Interventions

rapid salivary test DIAGNOSTIC_TEST

a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay

Asymptomatic subjects; Symptomatic patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection

You may not qualify if:

• none

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

ASST dei Sette Laghi

Varese, VA, 21100, Italy

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lorenzo Azzi

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The rapid salivary test will provide results within 5-10 minutes, while the rRT-PCR performed on nasopharyngeal swab shows results only after 6 hours, thus the outcome assessor of the experimental test is blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Consecutive recruitment of both patients with COVID-19 like symptoms (i.e., cough, fever, dyspnea) and patients with low risk phenotype

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 22, 2020
• Study Start: April 16, 2020
• Primary Completion: May 31, 2020
• Study Completion: July 31, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available at the end of the study, once statistical analyses is conducted
• Access Criteria: Contact Principal Investigator

Locations

IT (1)