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

June 13, 2023 updated by: Direction Centrale du Service de Santé des Armées

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Mandé, France, 94160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population is composed of people coming to a hospital or to a COVID screening center.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Direction Centrale du Service de Santé des Armées

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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