ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Coronavirus Infections with a site in Israel — 1 open to participants now, 2 under way, 1 of them phase 3. Coronavirus Infections · Israel.

Started
2020
with 10 others
Observational
6 of 18
none open now
Registered
2nd of 18
by date
Lead sponsor
1 of 18
Cordio Medical

Among the 18 studies in Coronavirus Infections with a site in Israel, this one is one of 11 that started in 2020, is one of 6 observational ones, and was the 2nd registered.

By phase

18 studies; the count open now beside each. This study's row is marked.

Observationalthis study6 · 0 open
Phase 26 · 0 open
Phase 35 · 1 open
Phase 41 · 0 open

By the year they started

First in 2020; this study’s year is marked. 11 started in 2020.

Size and results

Median enrollment 215 across the 12 interventional studies, 518 across the 6 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 18 studies in Coronavirus Infections with a site in Israel, or all of them as a file.
02

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.

03

Conditions studied

  • Coronavirus Infection

Keywords

  • COVID-19 positive
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 site
  • Rambam Medical Center
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2020 to primary completion in May 2021, 12 months.

Of 245 observational studies under Coronavirus Infections, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2020
First posted
Mar 27, 2020
StartActual
Apr 23, 2020
Primary completionActual
May 2, 2021
CompletionActual
Sep 29, 2021
Last update
Dec 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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