Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19

COVID-19 Clinical Trial

— SATCoV  

Official title:

Telemonitoraggio Domiciliare Della Saturazione Arteriosa di Ossigeno in Pazienti COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731583
• Other study ID #: 4985
• Status: Recruiting
• Start date: January 6, 2021
• Est. completion date: January 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Luca Richeldi, MD
• Phone: +390630157852
• Email: luca.richeldi[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-19 pandemic created an urgent need to implement digital health solutions for remote clinical management of infected patients who could be monitored at home. The Gemelli Polyclinic in Rome provided a digital health program (SATCOV) to monitor at home newly diagnosed COVID-19 patient, or after an early discharge from the COVID units.

A digital application and a wireless oximeter were provided to patients. Oxygen saturation, heart rate and body temperature were monitored. The aim is to evaluate the feasibility and safety of the oxygen saturation telemonitoring in COVID-19 patients.

Clinicians personalized their remote assistance defining specific alerts for each patient and/or required a timely hospitalization in a dedicated COVID unit if necessary.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2024
• Est. primary completion date: July 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (age>18)

• confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)

• clinical condition compatible with hospital discharge (for recoving COVID group) or home management (for ongoing COVID group)

Exclusion Criteria:

• non-autonomous patients

• patients without a smartphone and home internet connection

• patients unable to refer to emergency room in less than 2 hours or unable to observe home isolation

• the presence of severe comorbidities that could compromise the safety of telemonitoring

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Home pulse oximetry monitoring
A digital application and a wireless oximeter were provided to both groups. Oxygen saturation, heart rate and (optional) body temperature were monitored at least twice a day.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Agostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients without missing days of telemonitoring/total patients	Number of patients without missing days of telemonitoring/total patients	14 days
Secondary	Oxygen saturation measurements	Number of oxygen saturation measurements performed/total measurements required by protocol	14 days
Secondary	Number of subject hospitalized/total patients	Number of subject hospitalized/total patients	3 yars
Secondary	Descriptive statistics	Groups' description of their clinical and demographics characteristics	14 days
Secondary	Correlation between the number of comorbidities and smoking status and SpO2 nadir	Correlation between the number of comorbidities and smoking status and SpO2 nadir	14 days
Secondary	Cost efficacy	Calculation of resources spent per patient	14 days