Covid-19WARd-COVIDNCT04382235
Non-invasive Ventilatory Support of Patients Affected by COVID-19
An observational study of Covid-19, run by University of Milano Bicocca at 34 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- Non-invasive ventilatory support
- Type of treatment
- Medical device
- How many people
- 909 participants
- Where
- 34 sitesItaly
- Study dates
- 31 Mar 2020to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- Explicit refusal to participate in the study
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Italy34 sites
Policlinico San Marco - Ospedale Zingonia
Bergamo, BG, 24040
ASST Papa Giovanni XXIII - Bergamo
Bergamo
Azienda Ospedaliera - Universitaria di Bologna, Policlinico S. Orsola Malpighi
Bologna
ASST Spedali Civili - Brescia
Brescia
ASST Valle Olona - Ospedale di Busto Arsizio
Busto Arsizio
ASST Lariana - Ospedale Sant'Anna
Como
ASST Crema - Ospedale Maggiore di Crema
Crema
ASST Cremona - Ospedale di Cremona
Cremona
Istituto Clinico Humanitas Gavazzeni
Cremona
ASST Garda - Presidio di Desenzano del Garda
Desenzano del Garda
ASST Monza - Desio
Desio
ASST Spedali Civili -Ospedale di Gardone Val Trompia
Gardone Val Trompia
ASST Lecco - Ospedale "A. Manzoni"
Lecco
ASST Ovest milanese - Ospedale di Legnano
Legnano
ASST Lodi - Ospedale Maggiore di Lodi
Lodi
ASST OVEST Milanese - Ospedale di Magenta
Magenta
ASST Garda - Ospedale di Manerbio
Manerbio
ASST Mantova - Ospedale Carlo Poma
Mantua
ASST Melegnano e della Martesana - Presidio di Melzo-Gorgonzola
Melzo
ASST Fatebenefratelli - Presidi Fatebenefratelli & M. Melloni
Milan
ASST Fatebenefratelli - Sacco
Milan
ASST Grande Ospedale Metropolitano Niguarda
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Ospedale San Giuseppe
Milan
ASST Spedali Civili -Presidio Ospedaliero di Montichiari
Montichiari
ASST Monza - Ospedale San Gerardo
Monza
Fondazione IRCCS Policlinico San Matteo - Pavia
Pavia
Policlinico San Pietro
Ponte San Pietro
Istituto Clinico Humanitas Rozzano
Rozzano
ASST Valle Olona - Ospedale di Saronno
Saronno
ASST Bergamo OVEST - Ospedale "Treviglio-Caravaggio" di Treviglio
Treviglio
Ospedale di Circolo e Fondazione Macchi - Varese
Varese
ASST Vimercate - Ospedale di Vimercate
Vimercate
ASST Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
Vizzolo Predabissi
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid-19
- Being tested
- Non-invasive ventilatory support
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilatory supportDevice
Also called High-flow nasal cannulas (HFNC), Non-invasive ventilation (NIV), Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)
All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 related Pneumonia patients | The cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support. Receives: Device: Non-invasive ventilatory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until patient discharge from the hospital (approximately 5 months)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Until patient discharge from the hospital (approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start31 Mar 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 909 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382235
- Sponsor's protocol ID
- WARd-COVID
- Acronym
- WARd-COVID
- Status last verified
- Apr 2021
- First submitted
- 5 May 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31978945Huang 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.
PubMed 31986264Wu 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.
PubMed 32091533Bellani 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.
PubMed 33395553
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management Through Non-invasive Ventilatory Support of Patients Showing an Acute Respiratory Failure Related to COVID-19 in Non-intensive Wards
- ClinicalTrials.gov ID
- NCT04382235
- Acronym / sponsor ID
- WARd-COVID / WARd-COVID
- Conditions
- Covid-19
- Keywords
- Coronavirus, sars-covid-2, coronavirus infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 909 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Covid-19 related Pneumonia patients | – | Device: Non-invasive ventilatory supportThe cohort is defined by subjects with a diagnosis of COVID 19-related pneumonia requiring non-invasive ventilatory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Explicit refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilatory supportAlso: High-flow nasal cannulas (HFNC), Non-invasive ventilation (NIV), Continuous positive airway pressure (CPAP) delivered with a face mask or helmet (helmet)All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests. | Device | Covid-19 related Pneumonia patients |
Primary outcome
The number of patients treated with non-invasive ventilation devices.
Time frame: Until patient discharge from the hospital (approximately 5 months)
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.
4 secondary outcomes
Incidence of patients requiring mechanical ventilation
Time frame: Until patient discharge from the hospital (approximately 5 months)
Incidence of organ failure
Time frame: Until patient discharge from the hospital (approximately 5 months)
Duration of hospitalization
Time frame: Until patient discharge from the hospital (approximately 5 months)
Clinical outcome at hospital discharge
Time frame: Until patient discharge from the hospital (approximately 5 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 31986264Huang 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.
- Background: PubMed 32091533Wu 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.
- Derived from this study: PubMed 33395553Bellani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by University of Milano Bicocca at 34 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients treated with non-invasive ventilation devices. (time frame: Until patient discharge from the hospital (approximately 5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382235, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.