Use of Saliva for COVID-19 Diagnosis | NCT04953039

Studies
Use of Saliva for COVID-19 Diagnosis

NCT04953039

Sponsor

University of Milano Bicocca

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

109Actual

Phase

Not provided

Conditions

SARS-CoV2 Infection

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2020Actual

Primary Completion Date

Oct 12, 2021Actual

Completion Date

Oct 12, 2021Actual

First Submitted Date

Jun 8, 2021

First Submission Date that Met QC Criteria

Jul 3, 2021

First Posted Date

Jul 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2022

Last Update Posted Date

Jul 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected or confirmed SARS-CoV2 infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giorgio Novelli, MD	ASST Monza - Ospedale San Gerardo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASST MONZA - Ospedale San Gerardo		Monza	MB	20900	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided