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

Covid-19 Clinical Trial

— WARd-COVID  

Official title:

Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382235
• Other study ID #: WARd-COVID
• Status: Completed
• Start date: March 31, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2021
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 909
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19

Intervention

Device:
• Non-invasive ventilatory support
All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests.

Locations

Country	Name	City	State
Italy	ASST Papa Giovanni XXIII - Bergamo	Bergamo
Italy	Policlinico San Marco - Ospedale Zingonia	Bergamo	BG
Italy	Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi	Bologna
Italy	ASST Spedali Civili - Brescia	Brescia
Italy	ASST Valle Olona - Ospedale di Busto Arsizio	Busto Arsizio
Italy	ASST Lariana - Ospedale Sant'Anna	Como
Italy	ASST Crema - Ospedale Maggiore di Crema	Crema
Italy	ASST Cremona - Ospedale di Cremona	Cremona
Italy	Istituto Clinico Humanitas Gavazzeni	Cremona
Italy	ASST Garda - Presidio di Desenzano del Garda	Desenzano Del Garda
Italy	ASST Monza - Desio	Desio
Italy	ASST Spedali Civili -Ospedale di Gardone Val Trompia	Gardone Val Trompia
Italy	ASST Lecco - Ospedale "A. Manzoni"	Lecco
Italy	ASST Ovest milanese - Ospedale di Legnano	Legnano
Italy	ASST Lodi - Ospedale Maggiore di Lodi	Lodi
Italy	ASST OVEST Milanese - Ospedale di Magenta	Magenta
Italy	ASST Garda - Ospedale di Manerbio	Manerbio
Italy	ASST Mantova - Ospedale Carlo Poma	Mantova
Italy	ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola	Melzo
Italy	ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni	Milano
Italy	ASST Fatebenefratelli - Sacco	Milano
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
Italy	Ospedale San Giuseppe	Milano
Italy	ASST Spedali Civili -Presidio Ospedaliero di Montichiari	Montichiari
Italy	ASST Monza - Ospedale San Gerardo	Monza
Italy	Fondazione IRCCS Policlinico San Matteo - Pavia	Pavia
Italy	Policlinico San Pietro	Ponte San Pietro
Italy	Istituto Clinico Humanitas Rozzano	Rozzano
Italy	ASST Valle Olona - Ospedale di Saronno	Saronno
Italy	ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio	Treviglio
Italy	Ospedale di Circolo e Fondazione Macchi - Varese	Varese
Italy	ASST Vimercate - Ospedale di Vimercate	Vimercate
Italy	ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi	Vizzolo Predabissi

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. Erratum in: Lancet. 2020 Jan 30;:. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients treated with non-invasive ventilation devices.	The first purpose of the study is to evaluate the number of COVID-19 related pneumonia patients treated with devices for non-invasive ventilation outside intensive care units.	Until patient discharge from the hospital (approximately 5 months)
Secondary	Incidence of patients requiring mechanical ventilation	Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of patients requiring mechanical ventilation.	Until patient discharge from the hospital (approximately 5 months)
Secondary	Incidence of organ failure	Assess the clinical characteristics of patients treated with devices for non-invasive ventilation using the following endpoint: incidence of organ failure.	Until patient discharge from the hospital (approximately 5 months)
Secondary	Duration of hospitalization	Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: duration of hospitalization.	Until patient discharge from the hospital (approximately 5 months)
Secondary	Clinical outcome at hospital discharge	Measure the hospital outcomes of patients treated with devices for non-invasive ventilation using the following endpoint: clinical outcome at hospital discharge.	Until patient discharge from the hospital (approximately 5 months)