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Clinical Trials/NCT05892549
NCT05892549
Recruiting
Not Applicable

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

Direction Centrale du Service de Santé des Armées1 site in 1 country1,188 target enrollmentJune 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sars-CoV-2 Infection
Sponsor
Direction Centrale du Service de Santé des Armées
Enrollment
1188
Locations
1
Primary Endpoint
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2023
End Date
July 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Direction Centrale du Service de Santé des Armées
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening

Time Frame: Through study completion (36 months)

Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening

Time Frame: Through study completion (36 months)

Study Sites (1)

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