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.
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.
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
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Guido Bertolini, MD, Study Director
Istituto di Ricerche Farmacologiche Mario Negri IRCCS