Clinical trial NCT04497194: Registry of COVID-19 Patients at AOUI Verona
Official title: Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona).

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: AST (U/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona
timeFrame: through study completion, an average of 3 months
measure: Host-related factors associated with the pathogenesis of COVID-19
timeFrame: through study completion, an average of 3 months
measure: Virological factors associated with the pathogenesis of COVID-19
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University Hospital of Verona
Study officials:
References: