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

NCT ID: NCT05534074

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2025-01-01

Brief Summary

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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

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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

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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

Keywords

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COVID-19 SARS-CoV-2 COVID-19 registry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Liontos Angelos

Assistant Consultant of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Ioannina, Epirus, Greece

Site Status RECRUITING

Countries

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Greece

Facility Contacts

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Angelos Liontos, Consultant

Role: primary

Related Links

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https://diavgeia.gov.gr/decision/view/%CE%A829%CE%A846906%CE%97-9%CE%A40

Approval of the COVID-19 Registry from Administrative Board, Scientific Council, Ethics Committee and Research Committee of University Hospital of Ioannina, Greece

Other Identifiers

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2022-003051-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1282-3362

Identifier Type: OTHER

Identifier Source: secondary_id

ΑΔΑ: Ψ29Ψ46906Η-9Τ0

Identifier Type: OTHER

Identifier Source: secondary_id

ΑΔΑ: Ψ29Ψ46906Η-9Τ0

Identifier Type: OTHER

Identifier Source: secondary_id

4/21-4-2021 (Issue 24)

Identifier Type: -

Identifier Source: org_study_id