Use of Saliva for COVID-19 Diagnosis

NCT ID: NCT04953039

Last Updated: 2022-07-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2021-10-12

Brief Summary

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Aim of the study is to evaluate the presence of SARS-CoV2 RNA in the saliva of patients with suspected or confirmed COVID-19 in order to validate the analysis of this type of sample for the diagnosis of SARS-CoV2 infections.

Detailed Description

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Conditions

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SARS-CoV2 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years of age hospitalized in the COVID-19 wards of ASST Monza - San Gerardo Hospital with positive, weakly positive or negative nasopharyngeal swabs; initially assessed at the E.R.; symptomatic or asymptomatic with indication to hospitalization.
* Informed consent freely granted and acquired before the start of the study.

Exclusion Criteria

* Patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Giorgio Novelli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giorgio Novelli, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Monza - Ospedale San Gerardo

Locations

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ASST MONZA - Ospedale San Gerardo

Monza, MB, Italy

Site Status

Countries

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Italy

Other Identifiers

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SALIVA-01

Identifier Type: -

Identifier Source: org_study_id

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