COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDirection Centrale du Service de Santé des Armées
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
French speaking
Affiliated to a social security system
Owning a mobile phone capable of accessing the COVOICE application
Disqualifiers
Incapable adults
People deprived of their liberty
People under administrative or judicial supervision
Patients intubated or hospitalized in intensive care unit
Trial population
The study population is composed of people coming to a hospital or to a COVID screening center.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
COVOICE application use - initial
DeviceRecording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
COVOICE application use - follow-up
DeviceDaily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days
Treatment groups
1,188 Participants
are divided into 3 treatment groupsGroup A: COVID1 intervention
Group B: Other respiratory diseases1 intervention
Group C: Healthy1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Time frame
Through study completion (36 months)2
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Time frame
Through study completion (36 months)Sponsors and contacts
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Source ClinicalTrials.gov