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AzTrials

Coronavirus Disease 2019NCT04497194

Registry of COVID-19 Patients at AOUI Verona

An observational study of Coronavirus Disease 2019, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Coronavirus Disease 2019
What is being tested?
not applicable (observational study)
How many people
430 participants
Where
1 siteItaly
Study dates
1 Mar 2020to 30 Sep 2020
How long will I take part?
60 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Failure to obtain the informed consent.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Hospital of Verona

    Verona

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
not applicable (observational study)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • not applicable (observational study)Other

    not applicable (observational study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 3 months

  2. 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

    Measured: through study completion, an average of 3 months

  3. Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona

    Body temperature (°C)

    Measured: through study completion, an average of 3 months

  4. Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona

    Blood pressure (mmHg)

    Measured: through study completion, an average of 3 months

  5. Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

    Pulse rate (beats per minute)

    Measured: through study completion, an average of 3 months

  6. Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona

    Pulse rate (beats per minute)

    Measured: through study completion, an average of 3 months

  7. Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona

    Peripheral oxygen saturation (%)

    Measured: through study completion, an average of 3 months

  8. C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona

    CRP (m/gL)

    Measured: through study completion, an average of 3 months

  9. Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona

    PCT (ng/mL

    Measured: through study completion, an average of 3 months

  10. White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    White Blood Count (WBC, cell/mm3)

    Measured: through study completion, an average of 3 months

  11. Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Neutrophils (cell/mm3)

    Measured: through study completion, an average of 3 months

  12. Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Lymphocytes (cell/mm3)

    Measured: through study completion, an average of 3 months

  13. Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona

    Platelets (cell/mm3)

    Measured: through study completion, an average of 3 months

  14. L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona

    LDH (mU/ml)

    Measured: through study completion, an average of 3 months

  15. Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona

    CK (U/L)

    Measured: through study completion, an average of 3 months

  16. D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona

    D-dimer (μg/L)

    Measured: through study completion, an average of 3 months

  17. fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona

    fibrinogen (g/L)

    Measured: through study completion, an average of 3 months

  18. ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona

    ferritin (mcg/L)

    Measured: through study completion, an average of 3 months

  19. AST (U/L) in COVID-19 patients admitted to University Hospital of Verona

    AST (U/L)

    Measured: through study completion, an average of 3 months

  20. ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona

    ALT (U/L)

    Measured: through study completion, an average of 3 months

  21. Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona

    Creatinine (mg/dl)

    Measured: through study completion, an average of 3 months

  22. Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona

    pH

    Measured: through study completion, an average of 3 months

  23. Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

    pO2 (mmHg)

    Measured: through study completion, an average of 3 months

  24. Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona

    pCO2 (mmHg)

    Measured: through study completion, an average of 3 months

  25. Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona

    HCO3 (mmol/l)

    Measured: through study completion, an average of 3 months

  26. Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona

    SpO2 (%)

    Measured: through study completion, an average of 3 months

  27. Host-related factors associated with the pathogenesis of COVID-19

    IL-6 (pg/mL)

    Measured: through study completion, an average of 3 months

  28. Virological factors associated with the pathogenesis of COVID-19

    Nasal and rectal swabs, fecal samples and blood samples

    Measured: through study completion, an average of 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2020
  2. Study start1 Mar 2020
  3. Primary completion30 Aug 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
430 participants (actual)
Target duration
60 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497194
Sponsor's protocol ID
COVID19-VR
Status last verified
Jul 2021
First submitted
18 May 2020
Last updated
22 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus Disease 2019, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04497194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.

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