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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

COVID-19

Treatments

Device: Home pulse oximetry monitoring

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Recovering COVID
Description:
Subjects with hospitalization due to a confirmed diagnosis of Sars-CoV-2 infection, that were considered eligible for home monitoring.
Treatment:
Device: Home pulse oximetry monitoring
Ongoing COVID
Description:
Subjects with confirmed new diagnosis of Sars-CoV-2 infection, not requiring immediate hospitalization.
Treatment:
Device: Home pulse oximetry monitoring

Trial contacts and locations

1

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Central trial contact

Luca Richeldi, MD

Data sourced from clinicaltrials.gov

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