Risk Factors for COVID-19 Mortality

NCT04786808 | Terminated

• 1 other identifier: RF-COVID-AUSLPC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Virus Infection; Population at Risk; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Mortality rate

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

  28 days after admission

Secondary Outcomes (1)

• Need of invasive ventilation

  15 days after admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teodoro Marcianò: lead

Study Sites (1)

Azienda USL di Piacenza

Piacenza, Emilia-Romagna, 29121, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine, Emergency Medicine Specialist

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 8, 2021
• Study Start: January 15, 2021
• Primary Completion: November 7, 2021
• Study Completion: November 7, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

IT (1)