Clinical trial NCT04382235: Non-invasive Ventilatory Support of Patients Affected by COVID-19
Official title: Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Coronavirus
sars-covid-2
coronavirus infection
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 909
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on all patients diagnosed with COVID-related pneumonia in need of non-invasive ventilatory support. Patients will be enrolled on single day (March 26, 2020 or March 31, 2020 chosen by the participating centers).

Brief summary: Prospective, observational, multicenter study aiming to evaluate the number of COVID-19 pneumonia related patients treated with non-invasive ventilatory support outside the intensive care unit.

In addition, the study aims to obtain information related to the clinical characteristics and hospital results of these patients.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age\> = 18 years
* Diagnosis of COVID-related pneumonia requiring non-invasive ventilatory support (high-flow nasal cannula, and / or non-invasive ventilation and / or CPAP)

Exclusion Criteria:

- Explicit refusal to participate in the study

Primary outcomes:
measure: The number of patients treated with non-invasive ventilation devices.
timeFrame: Until patient discharge from the hospital (approximately 5 months)
Secondary outcomes:
measure: Incidence of patients requiring mechanical ventilation
timeFrame: Until patient discharge from the hospital (approximately 5 months)
measure: Incidence of organ failure
timeFrame: Until patient discharge from the hospital (approximately 5 months)
measure: Duration of hospitalization
timeFrame: Until patient discharge from the hospital (approximately 5 months)
measure: Clinical outcome at hospital discharge
timeFrame: Until patient discharge from the hospital (approximately 5 months)
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Policlinico San Marco - Ospedale Zingonia
state: BG
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - Bergamo
city: Bologna
country: Italy
facility: Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili - Brescia
city: Busto Arsizio
country: Italy
facility: ASST Valle Olona - Ospedale di Busto Arsizio
city: Como
country: Italy
facility: ASST Lariana - Ospedale Sant'Anna
city: Crema
country: Italy
facility: ASST Crema - Ospedale Maggiore di Crema
city: Cremona
country: Italy
facility: ASST Cremona - Ospedale di Cremona
city: Cremona
country: Italy
facility: Istituto Clinico Humanitas Gavazzeni
city: Desenzano Del Garda
country: Italy
facility: ASST Garda - Presidio di Desenzano del Garda
city: Desio
country: Italy
facility: ASST Monza - Desio
city: Gardone Val Trompia
country: Italy
facility: ASST Spedali Civili -Ospedale di Gardone Val Trompia
city: Lecco
country: Italy
facility: ASST Lecco - Ospedale "A. Manzoni"
city: Legnano
country: Italy
facility: ASST Ovest milanese - Ospedale di Legnano
city: Lodi
country: Italy
facility: ASST Lodi - Ospedale Maggiore di Lodi
city: Magenta
country: Italy
facility: ASST OVEST Milanese - Ospedale di Magenta
city: Manerbio
country: Italy
facility: ASST Garda - Ospedale di Manerbio
city: Mantova
country: Italy
facility: ASST Mantova - Ospedale Carlo Poma
city: Melzo
country: Italy
facility: ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola
city: Milano
country: Italy
facility: ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni
city: Milano
country: Italy
facility: ASST Fatebenefratelli - Sacco
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Giuseppe
city: Montichiari
country: Italy
facility: ASST Spedali Civili -Presidio Ospedaliero di Montichiari
city: Monza
country: Italy
facility: ASST Monza - Ospedale San Gerardo
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo - Pavia
city: Ponte San Pietro
country: Italy
facility: Policlinico San Pietro
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano
city: Saronno
country: Italy
facility: ASST Valle Olona - Ospedale di Saronno
city: Treviglio
country: Italy
facility: ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi - Varese
city: Vimercate
country: Italy
facility: ASST Vimercate - Ospedale di Vimercate
city: Vizzolo Predabissi
country: Italy
facility: ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
Study officials:
References:
citation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.
citation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
citation: Bellani G, Grasselli G, Cecconi M, Antolini L, Borelli M, De Giacomi F, Bosio G, Latronico N, Filippini M, Gemma M, Giannotti C, Antonini B, Petrucci N, Zerbi SM, Maniglia P, Castelli GP, Marino G, Subert M, Citerio G, Radrizzani D, Mediani TS, Lorini FL, Russo FM, Faletti A, Beindorf A, Covello RD, Greco S, Bizzarri MM, Ristagno G, Mojoli F, Pradella A, Severgnini P, Da Macalle M, Albertin A, Ranieri VM, Rezoagli E, Vitale G, Magliocca A, Cappelleri G, Docci M, Aliberti S, Serra F, Rossi E, Valsecchi MG, Pesenti A, Foti G. Noninvasive Ventilatory Support of Patients with COVID-19 outside the Intensive Care Units (WARd-COVID). Ann Am Thorac Soc. 2021 Jun;18(6):1020-1026. doi: 10.1513/AnnalsATS.202008-1080OC.