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RF-COVID: Risk Factors for COVID-19 Mortality

Sponsor
Teodoro Marcianò (Other)
Overall Status
Terminated
CT.gov ID
NCT04786808
Collaborator
(none)
200
Enrollment
1
Location
9.7
Actual Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for COVID-19 Mortality: a Prospective Observational Study
    Actual Study Start Date :
    Jan 15, 2021
    Actual Primary Completion Date :
    Nov 7, 2021
    Actual Study Completion Date :
    Nov 7, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Mortality rate [28 days after admission]

      Number of patients who die for any cause in the first 28 days after admission

    Secondary Outcome Measures

    1. Need of invasive ventilation [15 days after admission]

      Number of patients who need invasive ventilation in the first 15 days after admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda USL di Piacenza Piacenza Emilia-Romagna Italy 29121

    Sponsors and Collaborators

    • Teodoro Marcianò

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teodoro Marcianò, Doctor of Medicine, Emergency Medicine Specialist, Azienda Unità Sanitaria Locale di Piacenza
    ClinicalTrials.gov Identifier:
    NCT04786808
    Other Study ID Numbers:
    • RF-COVID-AUSLPC
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Nov 15, 2021