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Predictivity of Hemogasanalysis and Lung UltraSound in Determining COVID-19 Severity (COVID-PEGALUS)

S

San Donato Group (GSD)

Status

Unknown

Conditions

Covid19

Treatments

Diagnostic Test: Lung ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT04689672
COVID-PEGALUS

Details and patient eligibility

About

This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED).

Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months.

Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded.

The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • SARS - CoV 2 infection confirmed by positive RT-PCR on nasopharyngeal swab

Exclusion criteria

  • impossibility to perform lung ultrasound due to technical limitations.

Trial contacts and locations

1

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Central trial contact

Paola AM Maffi, MD, PhD

Data sourced from clinicaltrials.gov

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