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

NCT04382235 | Completed DMC

• 1 other identifier: WARd-COVID
• Study Type: observational
• Target: 909
• Locations: 1 country
• Sites: 34

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.

Conditions

Covid-19

Keywords

Coronavirus; sars-covid-2; coronavirus infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of patients requiring mechanical ventilation

  Until patient discharge from the hospital (approximately 5 months)

• Incidence of organ failure

  Until patient discharge from the hospital (approximately 5 months)

• Duration of hospitalization

  Until patient discharge from the hospital (approximately 5 months)

• Clinical outcome at hospital discharge

  Until patient discharge from the hospital (approximately 5 months)

Study Arms (1)

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

Interventions

Non-invasive ventilatory support DEVICE

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

Also known as: High-flow nasal cannulas (HFNC), Non-invasive ventilation (NIV), Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)

Covid-19 related Pneumonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• \- Explicit refusal to participate in the study

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (34)

Policlinico San Marco - Ospedale Zingonia

Bergamo, BG, 24040, Italy

Location

ASST Papa Giovanni XXIII - Bergamo

Bergamo, Italy

Location

Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi

Bologna, Italy

Location

ASST Spedali Civili - Brescia

Brescia, Italy

Location

ASST Valle Olona - Ospedale di Busto Arsizio

Busto Arsizio, Italy

Location

ASST Lariana - Ospedale Sant'Anna

Como, Italy

Location

ASST Crema - Ospedale Maggiore di Crema

Crema, Italy

Location

ASST Cremona - Ospedale di Cremona

Cremona, Italy

Location

Istituto Clinico Humanitas Gavazzeni

Cremona, Italy

Location

ASST Garda - Presidio di Desenzano del Garda

Desenzano del Garda, Italy

Location

ASST Monza - Desio

Desio, Italy

Location

ASST Spedali Civili -Ospedale di Gardone Val Trompia

Gardone Val Trompia, Italy

Location

ASST Lecco - Ospedale "A. Manzoni"

Lecco, Italy

Location

ASST Ovest milanese - Ospedale di Legnano

Legnano, Italy

Location

ASST Lodi - Ospedale Maggiore di Lodi

Lodi, Italy

Location

ASST OVEST Milanese - Ospedale di Magenta

Magenta, Italy

Location

ASST Garda - Ospedale di Manerbio

Manerbio, Italy

Location

ASST Mantova - Ospedale Carlo Poma

Mantova, Italy

Location

ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola

Melzo, Italy

Location

ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni

Milan, Italy

Location

ASST Fatebenefratelli - Sacco

Milan, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Ospedale San Giuseppe

Milan, Italy

Location

ASST Spedali Civili -Presidio Ospedaliero di Montichiari

Montichiari, Italy

Location

ASST Monza - Ospedale San Gerardo

Monza, Italy

Location

Fondazione IRCCS Policlinico San Matteo - Pavia

Pavia, Italy

Location

Policlinico San Pietro

Ponte San Pietro, Italy

Location

Istituto Clinico Humanitas Rozzano

Rozzano, Italy

Location

ASST Valle Olona - Ospedale di Saronno

Saronno, Italy

Location

ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio

Treviglio, Italy

Location

Ospedale di Circolo e Fondazione Macchi - Varese

Varese, Italy

Location

ASST Vimercate - Ospedale di Vimercate

Vimercate, Italy

Location

ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi

Vizzolo Predabissi, Italy

Location

Related Publications (4)

• 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.

  PMID: 31978945 BACKGROUND

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 33395553 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Noninvasive Ventilation; Continuous Positive Airway Pressure; Head Protective Devices

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Positive-Pressure Respiration; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 11, 2020
• Study Start: March 31, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: April 28, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (34)