Registry of COVID-19 Patients at AOUI Verona

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronavirus Disease 2019

Intervention / Treatment
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* Other: not applicable (observational study)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: not applicable (observational study)|not applicable (observational study)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona | Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms. | through study completion, an average of 3 months | 
| Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona | Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission | through study completion, an average of 3 months | 
| Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona | Body temperature (°C) | through study completion, an average of 3 months | 
| Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona | Blood pressure (mmHg) | through study completion, an average of 3 months | 
| Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona | Pulse rate (beats per minute) | through study completion, an average of 3 months | 
| Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona | Pulse rate (beats per minute) | through study completion, an average of 3 months | 
| Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona | Peripheral oxygen saturation (%) | through study completion, an average of 3 months | 
| C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona | CRP (m/gL) | through study completion, an average of 3 months | 
| Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona | PCT (ng/mL | through study completion, an average of 3 months | 
| White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona | White Blood Count (WBC, cell/mm3) | through study completion, an average of 3 months | 
| Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona | Neutrophils (cell/mm3) | through study completion, an average of 3 months | 
| Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona | Lymphocytes (cell/mm3) | through study completion, an average of 3 months | 
| Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona | Platelets (cell/mm3) | through study completion, an average of 3 months | 
| L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona | LDH (mU/ml) | through study completion, an average of 3 months | 
| Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona | CK (U/L) | through study completion, an average of 3 months | 
| D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona | D-dimer (μg/L) | through study completion, an average of 3 months | 
| fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona | fibrinogen (g/L) | through study completion, an average of 3 months | 
| ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona | ferritin (mcg/L) | through study completion, an average of 3 months | 
| AST (U/L) in COVID-19 patients admitted to University Hospital of Verona | AST (U/L) | through study completion, an average of 3 months | 
| ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona | ALT (U/L) | through study completion, an average of 3 months | 
| Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona | Creatinine (mg/dl) | through study completion, an average of 3 months | 
| Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona | pH | through study completion, an average of 3 months | 
| Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona | pO2 (mmHg) | through study completion, an average of 3 months | 
| Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona | pCO2 (mmHg) | through study completion, an average of 3 months | 
| Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona | HCO3 (mmol/l) | through study completion, an average of 3 months | 
| Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona | SpO2 (%) | through study completion, an average of 3 months | 
| Host-related factors associated with the pathogenesis of COVID-19 | IL-6 (pg/mL) | through study completion, an average of 3 months | 
| Virological factors associated with the pathogenesis of COVID-19 | Nasal and rectal swabs, fecal samples and blood samples | through study completion, an average of 3 months |