CORONABED_BOT: CORONABED.BOT -COVID-19: an Automation Project Using Artificial Intelligence for Early Diagnosis of Clinical Evolution From SARS-CoV-2"

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05787405
• Collaborator: (none)
• Enrollment: 8,000
• Location: 1
• Anticipated Duration (Months): 60.9
• Patients Per Site Per Month: 131.3

Study Details

Study Description

Brief Summary

The aim of the CORONA.BOT project is to exploit the Artificial Intelligence methods of Generator Real World Data Facility to automatically extract structured and unstructured data from hospital databases and to implement an early risk assessment (warning system) regarding the negative outcome for patients infected with SARS-CoV-2.

The objective of CORONABED.BOT is to analyze the care pathways of patients from the same cohort as CORONA.BOT, in order to identify the total length of stay, intensive care occupations and flows between departments, based on variables demographics and first entry clinics Early identification of patients with symptoms compatible with SARS-CoV-2 infection will enable more rapid activation of isolation procedures, contact monitoring/contact history and decisions on the most appropriate clinical pathway in terms of type of treatment and unit. Similarly, the identification of factors correlated with worse outcomes will allow more effective planning for the use of critical resources (such as intensive care and others).

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-1 Infection	Other: Artificial Intelligence methods

Study Design

• Study Type: Observational
• Anticipated Enrollment: 8000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: CORONABED.BOT: an Automation Project Using Artificial Intelligence for Early Diagnosis of Clinical Evolution From SARS-CoV-2"
• Actual Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Jun 15, 2025
• Anticipated Study Completion Date: Dec 30, 2025

Outcome Measures

Primary Outcome Measures

1. the implementation of prediction models [24 months]

   tThe DataMart built will allow the creation of predictive models both for diagnosis of SARS-coV-2 pneumonia as well as death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients (18 years of age or older)

• admitted to the Gemelli and Columbus Polyclinic

• diagnosis of SARS-CoV-2 infection (suspected cases will also be included).

Exclusion Criteria:

• aaaa

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Gemelli	Rome		Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05787405
• Other Study ID Numbers: CORONABED.BOT-COVID19- 3447
• First Posted: Mar 28, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of Mar 30, 2023