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
1 other identifier
observational
215
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2020
CompletedFirst Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedFebruary 21, 2023
February 1, 2023
1.7 years
February 15, 2021
February 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Severity of COVID-19 infection modelling
6 months
Study Arms (2)
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.
Eligibility Criteria
Peripheral blood smears obtained from adult non-SARS-CoV-2 positive patients and from adult positive SARS-CoV-2 patients.
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East Suffolk and North Essex NHS Foundation Trust
Ipswich, IP4 5PD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahesh Prahladan
East Suffolk and North Essex NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2021
First Posted
February 16, 2021
Study Start
July 6, 2020
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share