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

January 2, 2022 updated by: Emanuele Bosi, IRCCS San Raffaele

AI Evaluation of COVID-19 Sounds

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • (Mi)
      • Milano, (Mi), Italy, 20132
        • Recruiting
        • San Raffaele Hospital and Scientific Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Marco Montagna, Medicine, Vita-Salute San Raffaele University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 2, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI-EChOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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