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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: Device: Cordio App

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cordio Medical
• Investigators: Principal Investigator: Zaher Azzam, Prof, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2020
• Primary Completion (Actual): May 2, 2021
• Study Completion (Actual): September 29, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19 positive
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: COV001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No