Sars-CoV-2 InfectionCOVOICENCT05892549
COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
An observational study of Sars-CoV-2 Infection and COVID-19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV-2 Infection, COVID-19
- What is being tested?
- COVOICE application use - initial and COVOICE application use - follow-up
- Type of treatment
- Medical device
- How many people
- 1,188 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population is composed of people coming to a hospital or to a COVID screening center.
Who may be able to join
- French speaking
- Affiliated to a social security system
- Owning a mobile phone capable of accessing the COVOICE application
Who cannot join
- Incapable adults
- People deprived of their liberty
- People under administrative or judicial supervision
- Patients intubated or hospitalized in intensive care unit
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Hubert NIELLY, MD, 143985479 ext. +33, hubert.nielly@intradef.gouv.fr
About this study
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.
Read more
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.
- Conditions
- Sars-CoV-2 Infection, COVID-19
- Being tested
- COVOICE application use - initial, COVOICE application use - follow-up
- Keywords
- Voice
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVOICE application use - initialDevice
Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
COVOICE application use - follow-upDevice
Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days
| Study group | Role | What they receive |
|---|---|---|
| COVID | Not described Receives: Device: COVOICE application use - follow-up | |
| Other respiratory diseases | Not described Receives: Device: COVOICE application use - follow-up | |
| Healthy | Not described Receives: Device: COVOICE application use - initial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Measured: Through study completion (36 months)
Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Measured: Through study completion (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start12 Jun 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892549
- Sponsor's protocol ID
- 2020-COVID19-21
- Other IDs
- 2020-A03182-37
- Acronym
- COVOICE
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19: Early Detection of Worsening by Voice and Respiratory Pattern Characteristics
- ClinicalTrials.gov ID
- NCT05892549
- Acronym / sponsor ID
- COVOICE / 2020-COVID19-21
- Conditions
- Sars-CoV-2 Infection, COVID-19
- Keywords
- Voice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,188 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID | – | Device: COVOICE application use - follow-up |
| Other respiratory diseases | – | Device: COVOICE application use - follow-up |
| Healthy | – | Device: COVOICE application use - initial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of people coming to a hospital or to a COVID screening center.
Key inclusion criteria (3 listed)
- French speaking
- Affiliated to a social security system
- Owning a mobile phone capable of accessing the COVOICE application
Key exclusion criteria (4 listed)
- Incapable adults
- People deprived of their liberty
- People under administrative or judicial supervision
- Patients intubated or hospitalized in intensive care unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVOICE application use - initialRecording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application | Device | Healthy |
| COVOICE application use - follow-upDaily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days | Device | COVID, Other respiratory diseases |
Primary outcome
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV-2 Infection and COVID-19, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hubety NIELLY, MD (143985479 ext. +33, hubert.nielly@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening (time frame: Through study completion (36 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.