COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
COVOICE
2 other identifiers
observational
1,188
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
June 15, 2023
June 1, 2023
3.1 years
June 6, 2023
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Through study completion (36 months)
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Through study completion (36 months)
Study Arms (3)
COVID
Other respiratory diseases
Healthy
Interventions
Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days
Eligibility Criteria
The study population is composed of people coming to a hospital or to a COVID screening center.
You may qualify if:
- French speaking
- Affiliated to a social security system
- Owning a mobile phone capable of accessing the COVOICE application
You may not qualify if:
- Incapable adults
- People deprived of their liberty
- People under administrative or judicial supervision
- Patients intubated or hospitalized in intensive care unit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 7, 2023
Study Start
June 12, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
June 15, 2023
Record last verified: 2023-06