COVID-19AI-EChOSNCT05115097
AI Evaluation of COVID-19 Sounds (AI-EChOS)
An observational study of COVID-19 and COVID-19 Respiratory Infection, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Respiratory Infection, Cough
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2021to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital and Scientific Institute
Milan, (Mi), 20132
About this study
Official title: 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.
- Keywords
- COVID-19, artificial intelligence, machine learning, sound, cough, breath, voice, diagnosis, automation, AI, ML, pneumonia, symptoms, airways, SARS-CoV-2
- Medical subject headings
- COVID-19, Cough, Respiratory Sounds, Mouth Breathing, Disease, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy evaluation
The investigators will evaluate the accuracy of the ML algorithm in terms of sensitivity and specificity and ROC-AUC
Measured: September 2022-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start20 Sep 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele Bosi, IRCCS San Raffaele
- Investigators
- Marco Montagna, Medicine, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115097
- Sponsor's protocol ID
- AI-EChOS
- Acronym
- AI-EChOS
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI Evaluation of COVID-19 Sounds
- ClinicalTrials.gov ID
- NCT05115097
- Acronym / sponsor ID
- AI-EChOS / AI-EChOS
- Keywords
- COVID-19, artificial intelligence, machine learning, sound, cough, breath, voice, diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Montagna, Medicine principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID-19 Respiratory Infection, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Montagna, Medicine (+390226439744, montagna.marco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy evaluation (time frame: September 2022-December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.