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NCT05534074 Clinical Trial

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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05534074
Other study ID # 4/21-4-2021 (Issue 24)
Secondary ID 2022-003051-33U1
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date January 1, 2025

Study information
Verified date December 2023
Source University Hospital, Ioannina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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)

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date January 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - PCR positive for SARS-CoV-2 - hospitalization for COVID-19 disease in the Infectious Diseases Unit of University Hospital of Ioannina, greece Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Greece 1st Division of Internal Medicine and Infectious Diseases Unit, University Hospital of Ioannina Ioánnina Epirus

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Ioannina 1st Division of Internal Medicine, University Hospital of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary association of indices of COVID-19 severity with outcomes outcomes: respiratory failure, disease severity in CT, death, intubation, length of stay 5 years
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