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Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine

NCT06144333 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7500

Last updated 2024-04-15

No results posted yet for this study

Summary

Patients infected with SARS-CoV-2 can present with a wide range of manifestations clinical conditions, ranging from no symptoms to serious or chronic illness. The current gold standard test for the diagnosis of COVID-19 is based on a molecular test of reverse transcription polymerase chain reaction (RT-PCR), aimed at detecting the RNA of the virus in respiratory samples such as nasopharyngeal swabs or aspirates bronchial, other methods such as antigen tests and serological detection tests IgM and IgG in response to COVID-19 viral infection, can be used for the purposes of screening in the general population.

In this context of variety of existing tests, it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy, specificity and sensitivity of these tests in current clinical practice.

This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned, for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus, in terms of sensitivity, specificity, positive and negative predictive values, for the implementation of indicators quality monitoring of these kits.

Conditions

  • SARS CoV 2 Infection

Interventions

DIAGNOSTIC_TEST

RIPH2

* Blood sampling by capillary * Swab sampling * Blood sampling by venous punction * Salivary sample, sputum, expectoration:

Sponsors & Collaborators

  • CerbaXpert

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2025-12-10
Completion
2026-11-23

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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 NCT06144333 on ClinicalTrials.gov