Registry of COVID-19 Patients at AOUI Verona

NCT04497194 | Completed

• 1 other identifier: COVID19-VR
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (28)

• 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

Interventions

not applicable (observational study) OTHER

not applicable (observational study)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona).

You may qualify if:

• 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.

You may not qualify if:

• Failure to obtain the informed consent.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

University Hospital of Verona

Verona, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 60 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: August 4, 2020
• Study Start: March 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

IT (1)