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NCT Number: NCT05892549

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

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.

Recruiting

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, 94160, France

Location status: Recruiting

Location contact

Hubert NIELLY, MD

CONTACT

[email protected]

143985479 ext. +33

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVOICE application use - initial

Device

Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application

COVOICE application use - follow-up

Device

Daily recording of sound related to respiratory movements, coughing and voice using a mobile phone application. Duration: up to 30 days

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hubety NIELLY, MD

CONTACT

[email protected]

143985479 ext. +33

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: COVOICE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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