Clinical trial NCT04337502: Clinical and Radiomic Model of COVID-19
Official title: A Clinical and Radiological Model to Predict the Prognosis for COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Machine Learning
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Wuhan Central Hospital
First posted: 2020-04-07
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients

Brief 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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Predictive performance
timeFrame: Janunary 1, 2020, to February 13, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: The central hospital of Wuhan
state: Hubei
Study officials:
References: