NCT05892549

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,188 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Sars-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
DEVICE	COVOICE application use - initial	Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
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

Timeline

• Start date: 2023-06-12
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-06-07
• Last updated: 2023-06-15

Locations

1 site across 1 country: France