Prognostic Score in Covid-19

April 27, 2021 updated by: Clara Balsano, University of L'Aquila

Identification of a Clinical Score to Support the Clinician in Phase 2 of Covid-19

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • L'Aquila, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Italian Caucasian Patients ≥ 18 years old SARS-CoV-2 infection confirmed by PCR

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Validation cohort
Other: data collection
clinical data collection
Development cohort
Other: data collection
clinical data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prot. N. 71726

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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