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

Sponsor
Direction Centrale du Service de Santé des Armées (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05892549
Collaborator
(none)
1,188
1
37
32.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: COVOICE application use - initial
  • Device: COVOICE application use - follow-up

Study Design

Study Type:
Observational
Anticipated Enrollment :
1188 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
COVID

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

Other respiratory diseases

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

Healthy

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

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening [Through study completion (36 months)]

  2. Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening [Through study completion (36 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital d'Instruction des Armées Bégin Saint-Mandé France 94160

Sponsors and Collaborators

  • Direction Centrale du Service de Santé des Armées

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier:
NCT05892549
Other Study ID Numbers:
  • 2020-COVID19-21
  • 2020-A03182-37
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Direction Centrale du Service de Santé des Armées
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 7, 2023