Use of Saliva for COVID-19 Diagnosis

Completed

• Conditions: SARS-CoV2 Infection

• Registration Number: NCT04953039
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-19
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-07-03
• Study First Posted: 2021-07-07
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of SARS-CoV2 RNA in the saliva of patient with suspected or confirmed COVID-19.	Up to 52 weeks	Positive - Negative

Trial Locations

Locations (1)

ASST MONZA - Ospedale San Gerardo; 🇮🇹 Monza, MB, Italy