- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892549
COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics (COVOICE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hubety NIELLY, MD
- Phone Number: +33 143985479
- Email: hubert.nielly@intradef.gouv.fr
Study Locations
-
-
-
Saint-Mandé, France, 94160
- Recruiting
- Hôpital d'Instruction des Armées Begin
-
Contact:
- Hubert NIELLY, MD
- Phone Number: +33 143985479
- Email: hubert.nielly@intradef.gouv.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy
|
Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
|
COVID
|
Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application.
Duration: up to 30 days
|
Other respiratory diseases
|
Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application.
Duration: up to 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Time Frame: Through study completion (36 months)
|
Through study completion (36 months)
|
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Time Frame: Through study completion (36 months)
|
Through study completion (36 months)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-COVID19-21
- 2020-A03182-37 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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