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Prognostic Score in Covid-19

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ClinicalTrials.gov Identifier: NCT04780373
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Clara Balsano, University of L'Aquila

Brief Summary:
The aim of the study is to define the clinical and biochemical parameters that characterize COVID-19 patients with a negative prognostic evolution. Our clinical score will be capable to recognize patient with favorable prognosis or patient with poor prognosis by statistical data analysis.

Condition or disease Intervention/treatment
Covid19 Prognostic Parameters Other: data collection

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of a Clinical Score to Support the Clinician in Phase 2 of Covid-19
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Group/Cohort Intervention/treatment
Development cohort Other: data collection
clinical data collection

Validation cohort Other: data collection
clinical data collection




Primary Outcome Measures :
  1. Data collection of clinical and demographical parameters of patients affected by COVID-19 [ Time Frame: 8 months ]
    Data about sex, age, symptom start date, vital parameters, comorbidity, symptoms, hematochemicals blood tests, therapy, oxygen support, radiology, condition evaluation will be manual collected.


Secondary Outcome Measures :
  1. Application of statistical analysis on data of patients affected by COVID-19 [ Time Frame: 2 months ]
    The collected data will be analyzed through descriptive statistics analysis, ROC curves, regression analysis, and Machine Learning techniques to predict the prognosis of patients affected by COVID-19.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Italian Caucasian Patients ≥ 18 years old SARS-CoV-2 infection confirmed by PCR
Criteria

Inclusion Criteria:

  • patients over 18 and symptomatic and positive for COVID-19 by polymerase chain reaction assay for rhino-pharingeal swab

Exclusion Criteria:

  • Under 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780373


Locations
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Italy
University of L'Aquila
L'Aquila, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
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Responsible Party: Clara Balsano, Full Professor, University of L'Aquila
ClinicalTrials.gov Identifier: NCT04780373    
Other Study ID Numbers: prot. N. 71726
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No