Registry of COVID-19 Patients at AOUI Verona

Coronavirus Disease 2019 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497194
• Other study ID #: COVID19-VR
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2021
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: September 30, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections

Intervention

Other:
• not applicable (observational study)
not applicable (observational study)

Locations

Country	Name	City	State
Italy	University Hospital of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona	Neutrophils (cell/mm3)	through study completion, an average of 3 months
Primary	Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona	Lymphocytes (cell/mm3)	through study completion, an average of 3 months
Primary	Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona	Platelets (cell/mm3)	through study completion, an average of 3 months
Primary	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
Primary	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
Primary	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
Primary	fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona	fibrinogen (g/L)	through study completion, an average of 3 months
Primary	ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona	ferritin (mcg/L)	through study completion, an average of 3 months
Primary	AST (U/L) in COVID-19 patients admitted to University Hospital of Verona	AST (U/L)	through study completion, an average of 3 months
Primary	ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona	ALT (U/L)	through study completion, an average of 3 months
Primary	Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona	Creatinine (mg/dl)	through study completion, an average of 3 months
Primary	Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona	pH	through study completion, an average of 3 months
Primary	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
Primary	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
Primary	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
Primary	Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona	SpO2 (%)	through study completion, an average of 3 months
Primary	Host-related factors associated with the pathogenesis of COVID-19	IL-6 (pg/mL)	through study completion, an average of 3 months
Primary	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