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NCT05115097 Clinical Trial

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

COVID-19 Clinical Trial

— AI-EChOS  

Official title:
AI Evaluation of COVID-19 Sounds

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05115097
Other study ID # AI-EChOS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2021
Est. completion date December 2022

Study information
Verified date January 2022
Source IRCCS San Raffaele
Contact Marco Montagna, Medicine
Phone +390226439744
Email montagna.marco@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy San Raffaele Hospital and Scientific Institute Milano (Mi)

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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