Non-invasive Ventilatory Support of Patients Affected by COVID-19

In February 2020, the first case of transmission of the syndrome, indicated as COVID-19, was
reported in Italy. Unfortunately, during March 2020, the syndrome spread rapidly throughout
the country, affecting tens of thousands of patients, including several thousands have
requested hospitalization and some hospitalization in intensive care, putting a strain on the
entire regional health system.

Patients that present intermediate severity of the infection are often treated with
non-invasive ventilatory support which includes high-flow nasal cannulas (HFNC), non-invasive
ventilation (NIV), continuous positive airway pressure (CPAP) through face mask or helmet
(helmet).

The exponential growth in the number of patients has made the massive use of these devices
necessary even outside the intensive or semi-intensive wards where they are traditionally
used.

Epidemiological knowledge regarding the type of patients treated with this strategy and the
outcome of these patients are limited, but very important in a context of emergency.

Thus, the objective of this prospective multicenter study is to evaluate the number of
patients with COVID-19 related pneumonia, treated with non-invasive ventilatory support
outside the intensive care unit and to evaluate the clinical characteristics and hospital
outcomes of these patients.

SAMPLE SIZE (n. Patients):

The study will collect all patients with the inclusion criteria, so the study size being by
definition equal to the maximum size.

STUDY DESIGN:

Patients will be enrolled on a single day (March 26, 2020 or March 31, 2020 chosen by the
participating centres).

Total duration of the Study: 5 months (enrollment, collection and analysis of data).

Enrollment Start: March 26, 2020. Enrollment Closure: March 31, 2020. End of the Study
(indicative date, last visit, last patient): May 2020.

The patient will be enrolled in the study when informed consent is obtained.

In this phase, the following data are collected:

- Patient registration;

- Demographic and anthropometric data;

- Comorbidity

- Hospitalization data;

- Ventilation / Hemodynamics data;

- Blood chemistry tests.

Upon discharge other data will be collected such as the necessary intubation or intubation
date.

STATISTICAL ANALYSIS:

The enrolled cases will be counted and the percentages of the three types of non-invasive
ventilatory supports will be specifically described by centre. The heterogeneity of these
percentages will be assessed through a model with mixed effects.

The anamnestic and clinical data of the enrolled patients will be analysed through
descriptive statistics on continuous quantitative variables.

The impact of the type of ventilation and of the blood chemistry parameters and aspects of
comorbidity will be assessed with reference to the probability of developing a transition to
the death and to hospitalization in intensive care through a multinomial model.

These factors will also be included in a logistic model with outcome defined by patient
survival.