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

NCT ID: NCT05892549

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1188 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-12

Study Completion Date

2026-07-31

Brief Summary

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In some clinical forms of COVID-19, an uncontrolled hyper-inflammatory reaction known as a "cytokine storm" appears abruptly, around day 7, and is associated with rapid respiratory deterioration, requiring hospitalization in an intensive care unit (ICU).

At present, although risk factors for this severe form have been described, there are no validated criteria for determining which individual patients will develop this aggravation.

The study of respiratory sounds (amplitude, frequency, ...) has made it possible in other respiratory pathologies (e.g., chronic obstructive pulmonary disease) to predict exacerbations several days in advance.

Having a predictive respiratory pattern for worsening in COVID-19 would make it possible to anticipate the need for intensive care hospital beds, by means of a tool easily available on a mobile phone.

Detailed Description

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Conditions

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Sars-CoV-2 Infection COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID

COVOICE application use - follow-up

Intervention Type DEVICE

Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days

Other respiratory diseases

COVOICE application use - follow-up

Intervention Type DEVICE

Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days

Healthy

COVOICE application use - initial

Intervention Type DEVICE

Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application

Interventions

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COVOICE application use - initial

Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application

Intervention Type DEVICE

COVOICE application use - follow-up

Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* French speaking
* Affiliated to a social security system
* Owning a mobile phone capable of accessing the COVOICE application

Exclusion Criteria

* Incapable adults
* People deprived of their liberty
* People under administrative or judicial supervision
* Patients intubated or hospitalized in intensive care unit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital d'Instruction des Armées Bégin

Saint-Mandé, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Hubety NIELLY, MD

Role: CONTACT

143985479 ext. +33

Facility Contacts

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Hubert NIELLY, MD

Role: primary

143985479 ext. +33

Other Identifiers

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2020-A03182-37

Identifier Type: OTHER

Identifier Source: secondary_id

2020-COVID19-21

Identifier Type: -

Identifier Source: org_study_id

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