Non-invasive Ventilatory Support of Patients Affected by COVID-19 (WARd-COVID)

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

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.

Study Overview

• Status: Completed
• Conditions: Covid-19
• Intervention / Treatment: Device: Non-invasive ventilatory support

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.

• Study Type: Observational
• Enrollment (Actual): 909

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy
    • ASST Papa Giovanni XXIII - Bergamo
  • Bologna, Italy
    • Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi
  • Brescia, Italy
    • ASST Spedali Civili - Brescia
  • Busto Arsizio, Italy
    • ASST Valle Olona - Ospedale di Busto Arsizio
  • Como, Italy
    • ASST Lariana - Ospedale Sant'Anna
  • Crema, Italy
    • ASST Crema - Ospedale Maggiore di Crema
  • Cremona, Italy
    • ASST Cremona - Ospedale di Cremona
  • Cremona, Italy
    • Istituto Clinico Humanitas Gavazzeni
  • Desenzano Del Garda, Italy
    • ASST Garda - Presidio di Desenzano del Garda
  • Desio, Italy
    • ASST Monza - Desio
  • Gardone Val Trompia, Italy
    • ASST Spedali Civili -Ospedale di Gardone Val Trompia
  • Lecco, Italy
    • ASST Lecco - Ospedale "A. Manzoni"
  • Legnano, Italy
    • ASST Ovest Milanese - Ospedale di Legnano
  • Lodi, Italy
    • ASST Lodi - Ospedale Maggiore di Lodi
  • Magenta, Italy
    • ASST OVEST Milanese - Ospedale di Magenta
  • Manerbio, Italy
    • ASST Garda - Ospedale di Manerbio
  • Mantova, Italy
    • ASST Mantova - Ospedale Carlo Poma
  • Melzo, Italy
    • ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola
  • Milano, Italy
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Milano, Italy
    • ASST Grande Ospedale Metropolitano Niguarda
  • Milano, Italy
    • ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni
  • Milano, Italy
    • ASST Fatebenefratelli - Sacco
  • Milano, Italy
    • Ospedale San Giuseppe
  • Montichiari, Italy
    • ASST Spedali Civili -Presidio Ospedaliero di Montichiari
  • Monza, Italy
    • ASST Monza - Ospedale San Gerardo
  • Pavia, Italy
    • Fondazione IRCCS Policlinico San Matteo - Pavia
  • Ponte San Pietro, Italy
    • Policlinico San Pietro
  • Rozzano, Italy
    • Istituto Clinico Humanitas Rozzano
  • Saronno, Italy
    • ASST Valle Olona - Ospedale di Saronno
  • Treviglio, Italy
    • ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio
  • Varese, Italy
    • Ospedale Di Circolo E Fondazione Macchi - Varese
  • Vimercate, Italy
    • ASST Vimercate - Ospedale di Vimercate
  • Vizzolo Predabissi, Italy
    • ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
  • BG
    • Bergamo, BG, Italy, 24040
      • Policlinico San Marco - Ospedale Zingonia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Covid-19 related Pneumonia patients; The cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support.	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.; Other Names: High-flow nasal cannulas (HFNC); Non-invasive ventilation (NIV); Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Milano Bicocca

Publications and helpful links

General Publications

• 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;:
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; coronavirus infection; sars-covid-2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WARd-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No