NCT04953039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

11 months

First QC Date

June 8, 2021

Last Update Submit

July 24, 2022

Conditions

SARS-CoV2 Infection

Keywords

Salivary test

Outcome Measures

Primary Outcomes (1)

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

    Positive - Negative

    Up to 52 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with suspected or confirmed SARS-CoV2 infection.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST MONZA - Ospedale San Gerardo

Monza, MB, 20900, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Giorgio Novelli, MD

    ASST Monza - Ospedale San Gerardo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2021

First Posted

July 7, 2021

Study Start

November 19, 2020

Primary Completion

October 12, 2021

Study Completion

October 12, 2021

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

IT(1)