NCT04323878

Completed

Early CPAP in COVID-19 Patients With Respiratory Failure. A ...

Mario Negri Institute for Pharmacological Research Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

EC-COVID-PCS-Fenice

Study Type

observational

Actual enrollment (reported)

6,000

Locations

1 country

Sites

1

Timeline

Study Start

June 1, 2020

Actual (reported)

Primary Completion

May 31, 2021

Actual (reported)

Study Completion

December 15, 2022

Actual (reported)

Brief Summary

This cohort study aims at prospectively collecting detailed clinical information on patients positive to or suspected of COVID-19 visiting Italian emergency departments (EDs). The objectives of the study are:

1.To monitor and describe the COVID-19 patients visiting Italian EDs.
2.To assess the prognostic impact of demographics, clinical characteristics, risk factors and pre-existing diseases.
3.To develop a predictive model, providing estimates of the prognosis using multiple relevant factors.
4.To construct a detailed database to enable comparative effectiveness research (CER), with the goal of generating hypothesis of efficacy and effectiveness of treatments, therapies and interventions, in the management and treatment of COVID-19 patients.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 6,000 participants
Study completion date: December 15, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 25, 2020
Actual (reported)
First Posted
March 27, 2020
Actual (reported)
Study Start
June 1, 2020
Actual (reported)
Primary Completion
May 31, 2021
Actual (reported)
Study Completion
December 15, 2022
Actual (reported)

Last Updated: December 19, 2022
Status Verified: December 2021
Last Update Submitted: December 16, 2022

Conditions

Early CPAP Ventilation in COVID-19 Patients

Keywords

Early CPAP ventilationCOVID-19Emergency Departement

Outcome Measures

Primary Outcomes (1)

Death or need of intubation
The study outcomes will be death or need of intubation within 7 days since ED arrival.
7 days since ED arrival

Secondary Outcomes (1)

30-day mortality
30 days since ED arrival

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

All the ED patients positive to or suspected of COVID-19 infection with respitatory symptoms

You may qualify if:

All the ED patients positive to or suspected of COVID-19 infection with at least one of the following symptoms:

Sponsors & Collaborators

Mario Negri Institute for Pharmacological Research
Otherlead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Guido Bertolini, MD
Istituto Di Ricerche Farmacologiche Mario Negri
STUDY DIRECTOR

Enrollment

6,000 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 27, 2020

Study Start

June 1, 2020

Actual (reported)

fever

cough/dyspnea

SpO2 \< 95% in ambient air (\< 91% if BPCO patient).

positive Quick Walk Test

respiratory symptoms or admission in ED for respiratory reason

You may not qualify if:

age \< 18 years
intubated patients or patients discharged in ICU in 1 hour from ED arrival
denied consent

Contact the study team to confirm eligibility.

Primary Completion

May 31, 2021

Actual (reported)

Study Completion

December 15, 2022

Actual (reported)

Last Updated

December 19, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04323878
Data provider: ClinicalTrials.gov
Source updated: 2022-12-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:04 UTC

Locations

IT(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations