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

Recruiting

• Conditions: Sars-CoV-2 Infection; COVID-19

• Registration Number: NCT05892549
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-07
• Study Start: 2023-06-12
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1188

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening	Through study completion (36 months)
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening	Through study completion (36 months)

Trial Locations

Locations (1)

Hôpital d'Instruction des Armées Bégin; 🇫🇷 Saint-Mandé, France