Use of Saliva for COVID-19 Diagnosis

SARS-CoV2 Infection Clinical Trial

— SALIVA-01  

Official title:

Use of Saliva for Diagnosis of SARS-CoV2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953039
• Other study ID #: SALIVA-01
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: October 12, 2021

Study information

• Verified date: July 2022
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 12, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infections
• SARS-CoV2 Infection

Locations

Country	Name	City	State
Italy	ASST MONZA - Ospedale San Gerardo	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of SARS-CoV2 RNA in the saliva of patient with suspected or confirmed COVID-19.	Positive - Negative	Up to 52 weeks