NCT04325048

Completed

Clinical Evaluation of Cordio Application in Adult COVID-19 ...

Cordio Medical Source

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Other study identifiers

Sponsor study identifier

COV001

Study Type

observational

Actual enrollment (reported)

42

Locations

1 country

Sites

1

Timeline

Study Start

April 23, 2020

Actual (reported)

Primary Completion

May 2, 2021

Actual (reported)

Study Completion

September 29, 2021

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 42 participants
Study completion date: September 29, 2021
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 25, 2020
Actual (reported)
First Posted
March 27, 2020
Actual (reported)
Study Start
April 23, 2020
Actual (reported)
Primary Completion
May 2, 2021
Actual (reported)
Study Completion
September 29, 2021
Actual (reported)

Last Updated: December 12, 2023
Status Verified: December 2023
Last Update Submitted: December 11, 2023

Conditions

Coronavirus Infection

Keywords

COVID-19 positive

Outcome Measures

Primary Outcomes (1)

Voice anaysis
patient voice that is recorded during the study will be anylaysis with specific algorithms
1-2 years

Interventions

Cordio AppDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

+ years old

Sponsors & Collaborators

Cordio Medical
Industrylead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

Zaher Azzam, Prof
Rambam Health Care Campus
PRINCIPAL INVESTIGATOR

Enrollment

42 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 2 Months
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

April 23, 2020

Actual (reported)

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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).

You may not qualify if:

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)

Contact the study team to confirm eligibility.

Primary Completion

May 2, 2021

Actual (reported)

Study Completion

September 29, 2021

Actual (reported)

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04325048
Data provider: ClinicalTrials.gov
Source updated: 2023-12-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:34 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations