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Differential Leucocyte Count and Covid-19 Diagnosis

NCT04643860 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-01-26

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Differential Leucocyte Count (CLDC) device and algorithm

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.

Sponsors & Collaborators

  • Neuromed IRCCS

    lead OTHER

Principal Investigators

  • Licia Iacoviello · IRCCS Neuromed

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04643860 on ClinicalTrials.gov