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NCT05534074 | RECRUITING | COVID-19 (Coronavirus Disease 2019)


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

University Hospital, Ioannina

Information provided by (Responsible Party):

Lion

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

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 Type : OBSERVATIONAL
Estimated Enrollment : 2500 participants
Official Title : University Hospital of Ioannina COVID-19 Registry. Retrospective Datasource Registry of COVID-19 (Coronavirus Disease 2019) Hospitalized Patients
Actual Study Start Date : 2020-03-01
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2025-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT05534074


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Locations


RECRUITING

Greece, Epirus

1st Division of Internal Medicine and Infectious Diseases Unit, University Hospital of Ioannina

Ioánnina, Epirus, Greece, 45500

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