CClinicalTrials.gg
Sign In
CompletedNCT04325048Updated Dec 12, 2023

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

An observational study in Coronavirus Infection, sponsored by Cordio Medical. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by Cordio Medical · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Coronavirus Infection

Keywords

  • COVID-19 positive
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

COVID-19 positive patients, from medical center departments, ER, home/hotels hospitalization

Inclusion criteria

  1. 18+ years old
  2. 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.
  3. 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

Exclusion Criteria:

  1. Subjects, in the Investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia).
  2. Patients with severe alcohol or drug use.
  3. Women who are pregnant or lactating.
  4. Participating in another investigation therapy that may interfere with study results (according to investigator discretion)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (actual)
Target follow-up
2 Months
Patient registry
Yes

Interventions

  • DeviceCordio App

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

05

What researchers measure

Primary outcomes

  1. Voice anaysis

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

    Time frame: 1-2 years

06

Study locations

1 site
  • Rambam Medical Center
    Haifa, Israel
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04325048
Lead sponsor
Cordio Medical
Responsible party
Sponsor
First posted
Mar 27, 2020
Start date
Apr 23, 2020
Primary completion
May 2, 2021
Completion
Sep 29, 2021
Last update
Dec 12, 2023

Study contacts

Zaher Azzam, Prof
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

Cordio Medical

Start the discussion