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OpenTrials
Completed

NCT Number: NCT04953039

Use of Saliva for COVID-19 Diagnosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST MONZA - Ospedale San Gerardo

Monza, MB, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of SARS-CoV2 RNA in the saliva of patient with suspected or confirmed COVID-19.

    Time frame: Up to 52 weeks

    Positive - Negative

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

Use of Saliva for Diagnosis of SARS-CoV2 Infection

Acronym: SALIVA-01

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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