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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Home pulse oximetry monitoring

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Luca Richeldi, MD; Phone Number: +390630157852; Email: luca.richeldi@policlinicogemelli.it

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Agostino Gemelli IRCCS
      • Contact: Luca Richeldi; Phone Number: 0630156202; Email: luca.richeldi@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients of any gender, with confirmed diagnosis of Sars-CoV-2 infection by a positive nasopharyngeal and oropharyngeal swab (PCR or rapid test)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recovering COVID; Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring.	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.
Ongoing COVID; Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients without missing days of telemonitoring/total patients	Number of patients without missing days of telemonitoring/total patients	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation measurements	Number of oxygen saturation measurements performed/total measurements required by protocol	14 days
Number of subject hospitalized/total patients	Number of subject hospitalized/total patients	3 yars
Descriptive statistics	Groups' description of their clinical and demographics characteristics	14 days
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
Cost efficacy	Calculation of resources spent per patient	14 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 4985

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