Risk Factors for COVID-19 Mortality

Acute Respiratory Distress Syndrome Clinical Trial

— RF-COVID  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04786808
• Other study ID #: RF-COVID-AUSLPC
• Status: Terminated
• Start date: January 15, 2021
• Est. completion date: November 7, 2021

Study information

• Verified date: November 2021
• Source: Azienda Unità Sanitaria Locale di Piacenza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• COVID-19 Virus Infection
• Population at Risk
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Italy	Azienda USL di Piacenza	Piacenza	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Teodoro Marcianò

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Number of patients who die for any cause in the first 28 days after admission	28 days after admission
Secondary	Need of invasive ventilation	Number of patients who need invasive ventilation in the first 15 days after admission	15 days after admission