Clinical and Radiomic Model of COVID-19

Coronavirus Clinical Trial

Official title:

A Clinical and Radiological Model to Predict the Prognosis for COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337502
• Other study ID #: UM_2020_GY_COVID-19
• Status: Completed
• Start date: December 23, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2020
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

Description:

In December 2019, a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; earlier named as 2019-nCoV), emerged in Wuhan, China. The diseases caused by SARS-CoV-2 is COVID-19. As of March 8, 2020, more than 100 000 COVID-19 patients have been reported globally (more than 80 000 cases in China, more than 20 000 in other countries), and 3 600 patients (3 100 in China, 500 outside of China) have died. The outbreak of COVID-19 constitutes a Public Health Emergency of International Concern.

Among COVID-19 patients, around 80% are mild (non-severe) illness patients, who usually heal within two weeks. However, another 20% of patients may aggravate into a severe or critical illness which results in a longer hospital stay, and the mortality rate for such patients is 13.4%. Therefore, inchoate identification of the high-risk severe patients is extremely important for patient management and medical resource allocation. General quarantine and symptomatic treatment can be used for most non-severe patients, while a higher level of care and green channel to the intensive care unit (ICU) are helpful for severe patients. Previous studies have summarized the clinical and radiological characteristics of severe COVID-19 patients, while which factors are important predictors is still unclear.

Machine learning is a branch of artificial intelligence that enables us to learn knowledge and potential laws from the given data and to build a model for solving problems as human needs. In recent years, machine learning has been developed as a novel tool to analyze large amounts of data from medical records or images. Previous modeling studies focused on forecasting the potential international spread of COVID-19.

Therefore, our purpose is to develop and validate a machine-learning model based on clinical, laboratory, and radiological characteristics alone or combination of COVID-19 patients in the early stage without severe illness from multiple centers for the prediction of severe (or critical) illness in the following hospitalization to facilitate risk Assessment before and after symptoms and triage (home, hospitalization inward or ICU).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 3, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• confirmed COVID-19 patients by high-throughput sequencing or real-time reverse-transcriptase polymerase-chain-reaction (RT-PCR) assay for nasal and pharyngeal swab specimens.

Exclusion Criteria:

1. patients with severe illness when admitted;

2. time interval > 2 days between the admission and examinations;

3. absent data or delayed results

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Machine Learning

Intervention

Diagnostic Test:
• Machine learning model
Machine learning, such as logistic regression, random forest, and deep learning

Locations

Country	Name	City	State
China	The central hospital of Wuhan	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	The Central Hospital of Wuhan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive performance	AUC, accuracy, sensitivity, and specificity	Janunary 1, 2020, to February 13, 2020