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OpenTrials
Completed

NCT Number: NCT04325048

Clinical Evaluation of Cordio Application in Adult COVID-19 Virus Positive Patients

Study on adult patients positive to COVID-19 virus. After signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the Cordio App installed in a smartphone/tablet.

The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital admittance (COVID-19 positive) until patient defined as COVID-19 negative and free of relevant clinical symptoms.

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rambam Medical Center

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18+ years old
  • Diagnosed with COVID-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. Patients that diagnosed with pneumonia, should be confirmed by X-ray and/or CT.
  • Able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients).

Exclusion criteria

  • Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
  • Patients with severe alcohol or drug use.
  • Women who are pregnant or lactating.
  • Participating in another investigation therapy that may interfere with study results (according to investigator discretion)

Treatment and study plan

Cordio App

Device

Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app

Primary outcomes

  1. Voice anaysis

    Time frame: 1-2 years

    patient voice that is recorded during the study will be anylaysis with specific algorithms

Sponsors and collaborators

Lead sponsor

Cordio Medical

Industry

Registry information

Official study title

Single-Arm Observational Study Designed to Clinically Evaluate Cordio Application in Adult Patients Positive to COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2020
Registry last updated
Dec 12, 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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