Differential Leucocyte Count and Covid-19 Diagnosis

NCT04643860 | Withdrawn

• 1 other identifier: DEP_042020
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To date, the diagnosis of SARS-CoV-2 infection is made by identifying the viral RNA in samples collected through a nasopharyngeal swab or other respiratory samples but this technique, has several limitations for its application in a mass screening. Recently, it has been developed a new method of acquitting the occurrence of severe Sar-COV-2 infection, detecting the early rise in leukocyte levels which has a characteristic set of ratios of leukocyte types, which identify the pathogen. Primary aim of the Diagnostic Accuracy study is to validate the use of the point-of-care characteristic Differential Leucocyte Count (CLDC) device and algorithm to detect SARS-CoV-2 infection as a preliminary approach to a mass screening program. Secondary aims are to define if CLCD methods is able to detect SARS-CoV-2 infection earlier as compared to swab molecular testing. Subjects at low and high risk of Sar-Cov-2 infection will be tested, at the same time of the nasopharyngeal swab procedure in the morning, each recruited subject will be also tested using CLDC device and algorithm. On a voluntary base, subjects will also undergo blood drawing (3 ml) for hematological cytometric analyses, research personnel will administer a questionnaire on COVID 19 symptoms and risk factors and for contact traicing. Subjects testing positive on either CLDC test but negative at the swab will undergo on a voluntary basis new swab testing after two, 5 and possibly 8 days if still negative. It estimates to find between 150 and 200 positives in a population of 1000 subjects at different risk of infection.

Conditions

SARS-CoV-2 Infection Covid19

Keywords

SARS-CoV-2 Leucocyte General population

Outcome Measures

Primary Outcomes (1)

• validation

  Primary aim is to validate the use of the point-of-care characteristic Differential Leucocyte Count (CLDC) device and algorithm to detect SARS-CoV-2 infection as a preliminary approach to a mass screening program.

  4 months

Secondary Outcomes (1)

• test sensitivity

  4 months

Study Arms (1)

General population

Subjects, at low and high risk of SARS-Cov-2, who undergo the nasopharyngeal swab procedure for the diagnosis of SARS-CoV-2 infection will be consecutively recruited at the Clinic Laboratory of IRCCS Neuromed in Pozzilli and Diagnostica Medica Spa in Avellino, Italy.

Diagnostic Test: Differential Leucocyte Count (CLDC) device and algorithm

Interventions

Differential Leucocyte Count (CLDC) device and algorithm DIAGNOSTIC_TEST

Boold sample that detecting the early rise in leukocyte levels which has a characteristic set of ratios of leukocyte types, which identify the viral pathogen and distinguish it from a number of others. This test allows prediction of positives from full blood count results.

General population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects at low and high risk of Sar-Cov-2 infection, who undergo the nasopharyngeal swab procedure for the diagnosis of SARS-CoV-2 infection will be consecutively recruited at the Clinic Laboratory of IRCCS Neuromed in Pozzilli and Diagnostica Medica Spa in Avellino, Italy.

You may qualify if:

• Signing a written consent

You may not qualify if:

• None

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCCS INM Neuromed, Department of Epidemiology and Prevention

Pozzilli, IS, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample will be taken for testing the leucocytes count to identified the presence of SARS-CoV-2 and blood drawing (3 ml) for hematological cytometric analyses

MeSH Terms

Interventions

Algorithms

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Licia Iacoviello

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: November 25, 2020
• Study Start: January 15, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

IT (1)