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

• Conditions: Breathing Sound; COVID-19; COVID-19 Respiratory Infection; Cough; Breathing, Mouth

• Registration Number: NCT05115097
• Lead Sponsor: IRCCS San Raffaele

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 available

Study Timeline

• Study Start: 2021-09-20
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-02
• Last Update Posted: 2022-01-18
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

San Raffaele Hospital and Scientific Institute; 🇮🇹 Milano, (Mi), Italy