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Completed

NCT Number: NCT04497194

Registry of COVID-19 Patients at AOUI Verona

The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.

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Key information

Conditions

Coronavirus Disease 2019 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Verona

Verona, Italy

About this study

Anamnestic data are collected at the enrollment, while all the other clinical and epidemiological information are retrieved retrospectively from patients' medical records and electronic health records.

Serological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs) are collected within 48 hours after admission and during the hospital stay, according with routine internal procedures.The biological samples are stored at the University Laboratory for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM).

A dedicated database has been created and implemented to collect all the above mentioned information.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing swab;
  • All ages;
  • All genders;
  • Informed consent obtained.

Exclusion criteria

  • Failure to obtain the informed consent.

Treatment and study plan

Not applicable (Observational Study)

Other

not applicable (observational study)

Primary outcomes

  1. Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.

  2. Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission

  3. Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Body temperature (°C)

  4. Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Blood pressure (mmHg)

  5. Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Pulse rate (beats per minute)

  6. Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Pulse rate (beats per minute)

  7. Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Peripheral oxygen saturation (%)

  8. C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    CRP (m/gL)

  9. Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    PCT (ng/mL

  10. White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    White Blood Count (WBC, cell/mm3)

  11. Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Neutrophils (cell/mm3)

  12. Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Lymphocytes (cell/mm3)

  13. Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Platelets (cell/mm3)

  14. L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    LDH (mU/ml)

  15. Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    CK (U/L)

  16. D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    D-dimer (μg/L)

  17. fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    fibrinogen (g/L)

  18. ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    ferritin (mcg/L)

  19. AST (U/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    AST (U/L)

  20. ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    ALT (U/L)

  21. Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    Creatinine (mg/dl)

  22. Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    pH

  23. Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    pO2 (mmHg)

  24. Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    pCO2 (mmHg)

  25. Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    HCO3 (mmol/l)

  26. Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona

    Time frame: through study completion, an average of 3 months

    SpO2 (%)

  27. Host-related factors associated with the pathogenesis of COVID-19

    Time frame: through study completion, an average of 3 months

    IL-6 (pg/mL)

  28. Virological factors associated with the pathogenesis of COVID-19

    Time frame: through study completion, an average of 3 months

    Nasal and rectal swabs, fecal samples and blood samples

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 4, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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