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

Coronavirus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325048
• Other study ID #: COV001
• Status: Completed
• Start date: April 23, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: December 2023
• Source: Cordio Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 29, 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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)

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• COVID-19

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Cordio Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice anaysis	patient voice that is recorded during the study will be anylaysis with specific algorithms	1-2 years