Risk Factors for COVID-19 Mortality (RF-COVID)

November 7, 2021 updated by: Teodoro Marcianò

Risk Factors for COVID-19 Mortality: a Prospective Observational Study

COVID-19 pandemic has deeply burdened hospitals all over the world. A two-stage disease has been hypothesized due to quick worsening of clinical status after 7-10 days from the beginning of first symptoms, generally flu-like symptoms. Predicting clinical worsening could help to address major efforts towards higher risk patients.

During the last year most observational studies, generally retrospective, has been conducted, identifying some risk factors such as age, obesity, male gender, cardiovascular disease, COPD, diabetes etc.

The study goal is to collect systematically a variegate amount of clinical, biometric, laboratory and radiological data from patients admitted to the Emergency Medicine Ward of Piacenza Hospital (Italy), in order to prospectively analyze what characteristics are associated to higher risk of mortality.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia-Romagna
      • Piacenza, Emilia-Romagna, Italy, 29121
        • Azienda USL di Piacenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients admitted to the ward from the Emergency Department are proposed to participate to the study.

Patients admitted to the Emergency Medicine Ward have a COVID-19 pneumonia with respiratory failure at any stage of severity, with a PaO2/FiO2 ratio approximately between 100 and 300. Prevalence of severe cases changes according to the number of cases diagnosed in the community and consequently to the global number of admissions to the hospital. The study is intended to be conducted over a period of 1 year.

Description

Inclusion Criteria:

  • Admission to the Emergency Medicine Ward from the Emergency Department of Piacenza Hospital (Italy)
  • Confirmed COVID-19 diagnosis through molecular test obtained from nasal-pharyngeal swabs in the Emergency Department
  • Age above 18

Exclusion Criteria:

  • inability to obtain an informed consent due to neurological conditions.
  • patient's refusal to sign the informed consent
  • inability of researchers to recruit the patient in the first 24 hours from the admission.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 28 days after admission
Number of patients who die for any cause in the first 28 days after admission
28 days after admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need of invasive ventilation
Time Frame: 15 days after admission
Number of patients who need invasive ventilation in the first 15 days after admission
15 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teodoro Marcianò

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

November 7, 2021

Study Completion (Actual)

November 7, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF-COVID-AUSLPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe