Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05892549
  4. Details
NCT05892549 Clinical Trial

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

COVID-19 Clinical Trial

— COVOICE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05892549
Other study ID # 2020-COVID19-21
Secondary ID 2020-A03182-37
Status Recruiting
Phase
First received
Last updated
Start date June 12, 2023
Est. completion date July 2026

Study information
Verified date June 2023
Source Direction Centrale du Service de Santé des Armées
Contact Hubety NIELLY, MD
Phone 143985479
Email hubert.nielly@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1188
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• COVOICE application use - initial
Recording (only once) of sound related to respiratory movements, coughing and voice using a mobile phone application
• 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

Locations
Country Name City State
France Hôpital d'Instruction des Armées Bégin Saint-Mandé

Sponsors (1)
Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening Through study completion (36 months)
Primary Specificity of the respiratory pattern demonstrated in the COVID patients who experienced respiratory worsening Through study completion (36 months)
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure