RecruitingOBSERVATIONAL

COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics

This study is trying to find a way to predict if someone with COVID-19 is going to get seriously ill, like needing intensive care. Sometimes, COVID-19 can suddenly get much worse around day 7, even in people who seemed okay. While we know some things that increase risk, there's no clear way yet to tell which individual patients will have this happen. The researchers are using a special phone app called COVOICE. This app listens to your voice and breathing patterns. Similar methods have helped predict problems in other lung conditions. The idea is that if we can predict worsening COVID-19 earlier, hospitals can better prepare intensive care beds, and patients can get help sooner. The study is open to French-speaking adults who have a mobile phone and are part of a social security system.

At a glance

Status

Recruiting

Sponsor

Direction Centrale du Service de Santé des Armées

Enrolment target

1,188

Start

12 Jun 2023

Estimated completion

01 Jul 2026

Sars-CoV-2 Infection COVID-19

What is this study about?

When someone has COVID-19, their body usually fights off the infection. However, in some people, especially around day 7 after symptoms start, their body can have a very strong reaction, like a sudden 'storm' inside, which can cause their breathing to quickly get much worse. If this happens, they might need to go into intensive care in hospital to get more support.

At the moment, doctors know some things that might make someone more likely to get seriously ill with COVID-19, but there isn't a clear test to tell exactly which person will suddenly get worse. This makes it hard to plan and makes sure everyone gets the right care at the right time. Being able to predict this would be very helpful for both patients and hospitals.

This study hopes to find a way to predict these sudden changes using a simple tool: a mobile phone app called COVOICE. This app will listen to your voice and breathing patterns. Researchers have noticed in other lung conditions that changes in breathing sounds can sometimes predict when someone's health is about to get worse, days in advance. By listening for similar changes in people with COVID-19, the study aims to create an early warning system. If successful, this could help doctors know which patients need closer monitoring or early treatment, potentially preventing them from getting severely ill and making sure intensive care beds are ready if needed.

Key takeaways

Uses a phone app to analyse voice and breathing for COVID-19.
Aims to predict if symptoms will get worse, especially around day 7.
Could help hospitals prepare for patients needing intensive care.
Participation involves using an app, no clinic visits or new medications.
For adults aged 18+ who speak French and have a smartphone.
Aims to create an early warning system for COVID-19 complications.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. You also need to be able to speak French and have a working mobile phone that can download and use the COVOICE app. Importantly, you must also be part of a social security system, which usually means you have access to healthcare in France.

There are also some reasons why you wouldn't be able to join. For example, if you are currently in intensive care in hospital, or relying on a breathing machine like a ventilator, you wouldn't be eligible. The study also cannot include adults who are unable to make their own decisions or people who are in prison or under certain legal supervision.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Can you speak French comfortably?
Do you have a smartphone that can use new apps?
Are you part of a social security system (like having French health insurance)?
Are you currently not in intensive care or on a breathing machine?
Are you able to make your own decisions about joining the study?

Answer every question to see your result.

What does participation involve?

If you join this study, your main involvement will be using the COVOICE app on your mobile phone. You will use it initially, and then continue to use it for follow-up recordings. This app will record your voice and breathing sounds. The study aims to see if changes in these recordings can predict if your COVID-19 symptoms might get worse. There are no medications involved in this study, and you won't need to visit a clinic specifically for the study. The total duration of your participation will depend on how long you use the app for follow-up, which the study staff will explain.

Potential risks and benefits

Taking part in this study carries very few direct risks, as it mainly involves using a phone app to record your voice and breathing, which is a non-invasive process. Your privacy will be protected. A potential benefit is that if the study is successful, it could lead to a valuable tool for earlier detection of worsening COVID-19, helping many future patients get timely care. However, it's important to remember that this is a research study, and there's no guarantee it will directly benefit your health. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Hôpital d'Instruction des Armées Bégin
Verified postcode
Saint-Mandé, France· Recruiting

Common questions

What is the COVOICE app?

It's a mobile phone app designed to record your voice and breathing sounds to help researchers understand how COVID-19 affects them.

Will using the app diagnose or treat my COVID-19?

No, the app is purely for research. It will not diagnose or treat your condition. It aims to develop a tool for future use.

Do I need to go to a clinic for this study?

No, you can participate from home using your own mobile phone. There are no clinic visits required for the study itself.

Is my personal information kept private?

Yes, the study is designed to protect your privacy and keep your personal data confidential.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason, without affecting your medical care.

How to find out more

Hubety NIELLY, MD

hubert.nielly@intradef.gouv.fr 143985479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.