University Hospital of Ioannina COVID-19 (Coronavirus Disease 2019) Registry

Sponsor

University Hospital, Ioannina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05534074

Collaborator

1st Division of Internal Medicine, University Hospital of Ioannina (Other)

2,500

Enrollment

Location

58.1

Anticipated Duration (Months)

43.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

COVID-19 (Coronavirus Disease 2019) Registry of University Hospital of Ioannina. Retrospective datasource registry with quantitative and qualitative patient data from the hospital medical records. Epidemiological, clinical and laboratory parameters are recorded on 7 different time points (day: 1, 3, 5, 7, 9, 11, 15) concerning 793 variables of interest in an electronic (computerised) database. Patients are also followed-up after 90 days from hospital discharge (number of visits of follow-up depends on patient's health status) at the Post-COVID and Long-term effects of coronavirus (long COVID) outpatient clinic of University Hospital of Ioannina. Data from this outpatient clinic are also recorded in an electronic database (189 variables of concern for each patient)

Condition or Disease	Intervention/Treatment	Phase
COVID-19 (Coronavirus Disease 2019) COVID-19 Pandemic COVID-19 Pneumonia COVID-19 Respiratory Infection COVID-19 Acute Respiratory Distress Syndrome COVID-19-Associated Thromboembolism COVID-19-Associated Pneumonia COVID 19 Associated Coagulopathy

Detailed Description

This is a retrospective study of COVID-19 (Coronavirus Disease 2019) at the Infectious Diseases Unit of the University Hospital of Ioannina. Quantitative and qualitative patient data are collected from the hospital medical records. Epidemiological, clinical and laboratory parameters are recorded on 7 different time points (day: 1, 3, 5, 7, 9, 11, 15) concerning 793 variables of interest in an electronic (computerised) database. Patients are also followed-up after 90 days from hospital discharge (number of visits of follow-up depends on patient's health status) at the Post-COVID and Long-term effects of coronavirus (long COVID) outpatient clinic of University Hospital of Ioannina. Data from this outpatient clinic are also recorded in an electronic database (189 variables of concern for each patient) The investigators collect data from COVID-19 hospitalized patients in the Infectious Diseases Unit of the University Hospital of Ioannina, from March 1st 2020 and ongoing. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection was diagnosed by reverse real time transcription-polymerase chain reaction (RT-PCR) test performed on nasopharyngeal swab specimens. Data are obtained retrospectively using patients' medical records (hard copy and digital records). All medical records are imported in a digital database anonymously with a personal identifier code for each patient, as prespecified by study protocol.

All data are collected following the highest standards set by the respective European Guidelines for Good Clinical and Laboratory Practice in Research Studies/Protocols and in accordance with the Helsinki Declaration. All participants in the study receive a personal identifier code and are kept anonymous. The epidemiological, clinical and laboratory data are collected and stored without being linked to personal data of the patients, but only to the personal identifier code. Biological samples are not collected. The collected clinical and laboratory data are archived in electronic databases (793 variables of concern for each individual patient).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

University Hospital of Ioannina COVID-19 Registry. Retrospective Datasource Registry of COVID-19 (Coronavirus Disease 2019) Hospitalized Patients

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

association of indices of COVID-19 severity with outcomes [5 years]
outcomes: respiratory failure, disease severity in CT, death, intubation, length of stay