<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497194</url>
  </required_header>
  <id_info>
    <org_study_id>COVID19-VR</org_study_id>
    <nct_id>NCT04497194</nct_id>
  </id_info>
  <brief_title>Registry of COVID-19 Patients at AOUI Verona</brief_title>
  <official_title>Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Universitaria Integrata Verona</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The registry of COVID-19 patients was designed to collect epidemiolgical, demographic,&#xD;
      clinical, anamnestic and outcome information together with serological and microbiological&#xD;
      samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda&#xD;
      Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted&#xD;
      and able to give an informed consent are included, irrespectively of age and gender.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anamnestic data are collected at the enrollment, while all the other clinical and&#xD;
      epidemiological information are retrieved retrospectively from patients' medical records and&#xD;
      electronic health records.&#xD;
&#xD;
      Serological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs)&#xD;
      are collected within 48 hours after admission and during the hospital stay, according with&#xD;
      routine internal procedures.The biological samples are stored at the University Laboratory&#xD;
      for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM).&#xD;
&#xD;
      A dedicated database has been created and implemented to collect all the above mentioned&#xD;
      information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>60 Days</target_duration>
  <primary_outcome>
    <measure>Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Body temperature (°C)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Blood pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Pulse rate (beats per minute)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Pulse rate (beats per minute)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Peripheral oxygen saturation (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>CRP (m/gL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>PCT (ng/mL</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>White Blood Count (WBC, cell/mm3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Neutrophils (cell/mm3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Lymphocytes (cell/mm3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Platelets (cell/mm3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>LDH (mU/ml)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>CK (U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>D-dimer (μg/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>fibrinogen (g/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>ferritin (mcg/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AST (U/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>AST (U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>ALT (U/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Creatinine (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>pH</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>pO2 (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>pCO2 (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>HCO3 (mmol/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>SpO2 (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Host-related factors associated with the pathogenesis of COVID-19</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>IL-6 (pg/mL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Virological factors associated with the pathogenesis of COVID-19</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>Nasal and rectal swabs, fecal samples and blood samples</description>
  </primary_outcome>
  <enrollment type="Actual">430</enrollment>
  <condition>Coronavirus Disease 2019</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>not applicable (observational study)</intervention_name>
    <description>not applicable (observational study)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera&#xD;
        Universitaria Integrata, AOUI Verona).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing&#xD;
             swab;&#xD;
&#xD;
          -  All ages;&#xD;
&#xD;
          -  All genders;&#xD;
&#xD;
          -  Informed consent obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to obtain the informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Verona</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Universitaria Integrata Verona</investigator_affiliation>
    <investigator_full_name>Evelina Tacconelli</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497194
org study id: COVID19-VR
nct id: NCT04497194
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Other
measure: 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
description: Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.
measure: 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
description: Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission
measure: 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
description: Body temperature (°C)
measure: 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
description: Blood pressure (mmHg)
measure: 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
description: Pulse rate (beats per minute)
measure: 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
description: Pulse rate (beats per minute)
measure: 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
description: Peripheral oxygen saturation (%)
measure: 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
description: CRP (m/gL)
measure: Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: PCT (ng/mL
measure: 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
description: White Blood Count (WBC, cell/mm3)
measure: Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: Neutrophils (cell/mm3)
measure: Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: Lymphocytes (cell/mm3)
measure: Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: Platelets (cell/mm3)
measure: 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
description: LDH (mU/ml)
measure: 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
description: CK (U/L)
measure: D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: D-dimer (μg/L)
measure: fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: fibrinogen (g/L)
measure: ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: ferritin (mcg/L)
measure: AST (U/L) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: AST (U/L)
measure: ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: ALT (U/L)
measure: Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona
time frame: through study completion, an average of 3 months
description: Creatinine (mg/dl)
measure: 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
description: pH
measure: 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
description: pO2 (mmHg)
measure: 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
description: pCO2 (mmHg)
measure: 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
description: HCO3 (mmol/l)
measure: 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
description: SpO2 (%)
measure: Host-related factors associated with the pathogenesis of COVID-19
time frame: through study completion, an average of 3 months
description: IL-6 (pg/mL)
measure: Virological factors associated with the pathogenesis of COVID-19
time frame: through study completion, an average of 3 months
description: Nasal and rectal swabs, fecal samples and blood samples
intervention type: Other
intervention name: not applicable (observational study)
description: not applicable (observational study)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Universitaria Integrata Verona
investigator full name: Evelina Tacconelli
investigator title: Professor
mesh term: COVID-19
sharing ipd: Undecided