NCT05534074

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: University Hospital, Ioannina · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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)

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).

Conditions

• 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

Timeline

• Start date: 2020-03-01
• Primary completion: 2024-12-31
• Completion: 2025-01-01
• First posted: 2022-09-09
• Last updated: 2023-12-19

Locations

1 site across 1 country: Greece