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NCT05892549 Clinical Trial

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

COVID-19 Clinical Trial

— COVOICE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05892549
Other study ID # 2020-COVID19-21
Secondary ID 2020-A03182-37
Status Recruiting
Phase
First received
Last updated
Start date June 12, 2023
Est. completion date July 2026

Study information
Verified date June 2023
Source Direction Centrale du Service de Santé des Armées
Contact Hubety NIELLY, MD
Phone 143985479
Email hubert.nielly@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1188
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• COVOICE application use - initial
Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
• 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

Locations
Country Name City State
France Hôpital d'Instruction des Armées Bégin Saint-Mandé

Sponsors (1)
Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening Through study completion (36 months)
Primary Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening Through study completion (36 months)
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