COVID-19 Infection and Machine Learning Using Artificial Intelligence (AI)

Rapid Diagnosis of COVID-19 Positive Patients With Artificial Intelligence (AI) Algorithm Using Clinical and Image Analytical Parameters to Evaluate the Lymphocyte Subsets in the Peripheral Blood

COVID-19 infection is currently confirmed by a complex, multiple-step procedure starting with a mucosal swab, followed by viral RNA extraction and processing and qPCR.

This study aims to explore a novel method using machine learning and artificial intelligence (AI) algorithm to diagnose COVID-19 infection through the morphological analysis of lymphocyte subset in the peripheral blood. This study will also risk stratify patients with COVID 19 infection based on the above finding along with other clinical, haematological and biochemical parameters with a view to predict clinical outcome with high sensitivity and specificity.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV 2; COVID

Detailed Description

This is an observational study which will be carried out at East Suffolk and North Essex NHS Foundation Trust (ESNEFT) in collaboration with University of Suffolk (UoS).

Investigators aim to analyse subsets of lymphocytes in the prospective blood smear slides using machine learning and AI algorithm obtained from participants with a positive qPCR test for COVID-19 who have required a hospital admission. The control group will consist of archived blood smear slide data from patients both with i) non-suspected viral infections, and ii) those with a non-COVID-19 viral infection obtained prior to the emergence of COVID-19 infection in the United Kingdom. In total, 785 blood smear slides will be analysed. The aim of this study is to establish the diagnosis of COVID 19 infection based on lymphocyte morphology on patients with COVID-19 infection from other patients with non COVID -19 viral infections. A high definition single cell lymphocyte image from patients with COVID 19 infection and control group will be analysed using open source histopathology imaging software CellProfiler against very fine cytoplasmic and nuclear details of the cells through supervised and unsupervised machine learning algorithm to identify recurring pattern that is unique to COVID 19 infection. The study will also assess other relevant clinical, haematological and biochemical parameters in conjunction with the above morphological features to develop a risk stratification tool to predict the clinical outcome of patients with COVID-19 infection with high specificity and sensitivity using bioinformatics pipeline.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

• Study Contact: Name: ESNEFT R&D department; Phone Number: 6343 01473 704343; Email: R&D@esneft.nhs.uk

Study Locations

• United Kingdom
  • Ipswich, United Kingdom, IP4 5PD
    • East Suffolk and North Essex NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peripheral blood smears obtained from adult non-SARS-CoV-2 positive patients and from adult positive SARS-CoV-2 patients.

Description

Inclusion Criteria:

• Female or male participants
• Aged over 18 years old (no upper age limit)
• Patients with SARS-COV-2 positive diagnosis based on qPCR (Study COVID 19 group)
• Peripheral blood smear slides from patients with no viral infection, reposited in the laboratory slides archive within the facility prior to the emergence of COVID-19 infection in the United Kingdom (Control group)
• Peripheral blood smear slides from patients with a non-SARS-CoV-2 viral infection that were reposited in the laboratory slides archive within the facility prior to the emergence of COVID-19 infection in the United Kingdom (Control group).

Exclusion Criteria:

• Patients that are less than 18 years old
• Patients with SARS-COV-2 negative diagnosis based on qPCRPatients who have been haematological malignancies with lymphocytosis as predominant manifestation.
• Patients who have lymphopenia in the past due to underlying inflammatory disorders.
• Patients who have lymphopenia due to previous cytotoxic or immunosuppressive therapy.
• Positive diagnosis of Human Immunodeficiency Virus (HIV).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
COVID 19 group; The COVID 19 group will consist of peripheral blood smear slides from patients who are in the hospital who had qPCR results positive for COVID-19.
CONTROL group; A control group will consist of i) peripheral blood smear slides from patients with no viral infection and ii) from those with a non-SARS-CoV-2 viral infection. Control group peripheral blood slides will be randomly selected from the laboratory slides archive within the facility. The laboratory slides used will be inclusive of slides archived prior to the emergence of COVID-19 infection in the United Kingdom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of COVID-19.	Determine whether lymphocytes alone can diagnose COVID-19 disease with high specificity and sensitivity, using AI-based image analytical modelling.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of COVID-19 infection modelling	The secondary outcome measure of the study will be to create risk stratification modelling, to aid in predicting the severity and mortality of the infection, based on our above-mentioned, novel diagnostic tool and additional clinical, haematological and biochemical parameters; ensuring high specificity, with consequent facilitated management of patients both in a hospital and outpatient setting. The model proposed intends to use and evaluate the clinical parameters including oxygen saturation at the time of venesection, and other vital statistics, including: pulse, blood pressure and respiratory rate, along with other parameters such as LDH, ferritin, C-reactive protein (CRP), D-dimers, renal function, all together helping to predict disease outcome and severity.	6 months

Collaborators and Investigators

• Sponsor: East Suffolk and North Essex NHS Foundation Trust
• Collaborators: University of Suffolk

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20/053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No