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

November 2, 2020 updated by: Lorenzo Azzi, Università degli Studi dell'Insubria

Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VA
      • Varese, VA, Italy, 21100
        • Asst Dei Sette Laghi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptomatic patients
Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.
Diagnostic test: rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
Active Comparator: 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.
Diagnostic test: rapid salivary test
a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility
Time Frame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.
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
Time Frame: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Lorenzo Azzi, Università degli Studi dell'Insubria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2020

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 18, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We could provide anamnestic, clinical and serological data of each participant at the end of the study, or at least at the end of the first phase.

IPD Sharing Time Frame

Data will be available at the end of the study, once statistical analyses is conducted

IPD Sharing Access Criteria

Contact Principal Investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

Study Data/Documents

  1. Scientific paper
    Information identifier: 10.1016/j.jinf.2020.06.042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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