Early CPAP in COVID-19 Patients With Respiratory Failure. A Prospective Cohort Study. (EC-COVID-PCS)

EC-COVID-PCS - Early CPAP in COVID Patients With Respiratory Failure. A Prospective Cohort Study.

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.

Study Overview

• Status: Completed
• Conditions: Early CPAP Ventilation in COVID-19 Patients

Detailed Description

All the ED patients positive to or suspected of COVID-19 infection will be included in the study. Descriptive reports of the collected data will be produced regularly. Different levels of aggregation will be considered: single center, province, region. In addition to providing useful elements to describe the evolution of the epidemic, the results presented in these reports will provide an accurate clinical description of a large sample of COVID-19 patients.

The study data will be leveraged to identify the most important risk factors and clinical conditions to predict poor patient outcomes. The most relevant factors will be selected using state-of-the-art techniques.

These factors will be used as predictors in multivariable predictive models, which will be developed to estimate the expected prognosis of the patients. The study outcomes will be death or need of intubation within 7 days since ED arrival and 30-day mortality. Given the dichotomous nature of these variables, the models will be developed with logistic regression. The models will be first developed when the study will enroll the minimum number of necessary patients, and periodically updated. In this way, predictive tools capable of making accurate estimates of the prognosis of patients will be returned to the clinical practice as soon as possible.

The study will record the use of treatments and drugs, such as antivirals, ACE inhibitors and sartans, whose effect on COVID-19 patients is not yet clear and mostly based on small studies. The large cohort of patients will be used to perform CER analyses and evaluate the effect of these treatments on the prognosis of patients, with appropriate statistical methodology to account for the observational nature of the data. These results will be used to refine and improve the experimental design of this project.

• Study Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality	30-day mortality	30 days since ED arrival

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Study Director: Guido Bertolini, MD, Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Early CPAP ventilation; Emergency Departement
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: EC-COVID-PCS-Fenice

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