AI Evaluation of COVID-19 Sounds (AI-EChOS) | NCT05115097

Studies
AI Evaluation of COVID-19 Sounds (AI-EChOS)

NCT05115097

Sponsor

IRCCS San Raffaele

Status

Unknown status

Last Update Posted

Jan 18, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19
COVID-19 Respiratory Infection
Cough
Breathing Sound
Breathing, Mouth

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2021Actual

Primary Completion Date

Sep 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Nov 9, 2021

First Submission Date that Met QC Criteria

Nov 9, 2021

First Posted Date

Nov 10, 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

Jan 2, 2022

Last Update Posted Date

Jan 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emanuele Bosi, Clinical Professor, Head of Endocrino-Metabolic and Diabetologic Medicine, IRCCS San RaffaelePrincipal Investigator

Lead Sponsor

IRCCS San RaffaeleOTHER

Collaborators

Not provided

Description Module

Brief Summary

In this study the investigators record sounds of voice, breaths and cough of subjects who tested positive for COVID19. The investigators then feed these sounds into an artificial intelligence and see if it can learn to recognise features to make COVID19 diagnosis from these sounds in order to avoid to use swabs to test the general population.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy evaluation	The investigators will evaluate the accuracy of the ML algorithm in terms of sensitivity and specificity and ROC-AUC	September 2022-December 2022

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults who tested positive for SARS-CoV-2 currently admitted to hospital at the study site
Adults who tested negative for SARS-CoV-2 and are admitted for any respiratory condition (eg COPD or asthma flare-up, pneumonia..)
Healthy volunteers

Exclusion Criteria:

Patients under the age of 18.
Patients unable to read in Italian.
Patients unable to give informed consent to participate.
Patients requiring life support (including, but not limited to, mechanical cardiac support, ventilation, etc.)
Patients who are pregnant

Accepts Healthy Volunteers

Yes

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

Study participants from the general population meeting the inclusion criteria will be included in three cohorts:

SARS-CoV-2 positive
SARS-CoV-2 negative but with respiratory disease
Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marco Montagna, Medicine	Contact	+390226439744		montagna.marco@hsr.it

Overall Officials

Name	Affiliation	Role
Marco Montagna, Medicine	Università Vita-Salute San Raffaele	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Raffaele Hospital and Scientific Institute	Recruiting	Milan	(Mi)	20132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D003371	Cough
D012135	Respiratory Sounds
D009058	Mouth Breathing
D004194	Disease
D011014	Pneumonia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided