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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

rapid salivary test

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring SARS-CoV-2, COVID-19, Saliva, nCoV-2019, Coronavirus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

none

Sites / Locations

ASST dei Sette Laghi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Symptomatic patients

Asymptomatic subjects

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Sensibility

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

Specificity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04357327

First Posted

April 15, 2020

Last Updated

November 2, 2020

Sponsor

Università degli Studi dell'Insubria

1. Study Identification

Unique Protocol Identification Number

NCT04357327

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

April 16, 2020 (Actual)

Primary Completion Date

May 31, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Università degli Studi dell'Insubria

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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

Allocation

Non-Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Symptomatic patients

Arm Type

Experimental

Arm Description

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

Arm Title

Asymptomatic subjects

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

rapid salivary test

Intervention Description

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

Primary Outcome Measure Information:

Title

Sensibility

Description

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

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.

Title

Specificity

Description

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

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.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Azzi

Organizational Affiliation

Università degli Studi dell'Insubria

Official's Role

Principal Investigator

Facility Information:

Facility Name

ASST dei Sette Laghi

City

Varese

State/Province

ZIP/Postal Code

21100

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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