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

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.

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Key information

Conditions

SARS CoV 2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient over 18 years old
Patient coming for a biological analysis as part of the care for prevention, screening or monitoring of the pathogen target
Patient able to understand the information note and give a free and informed consent, on paper or digital media
Clinical patients:

Control cases (all comers or ambulatory)
Known positive for the pathology concerned
Patient hospitalized for the pathology concerned
Pregnant or breastfeeding patient
Dialysis patient

Exclusion criteria

Patient already included in a research protocol
Patient having received medication or treatment experimental or investigational during the last four weeks before collection
Patient subject to a legal protection measure
Patient affiliated with state medical aid (AME)
Patient not affiliated to the compulsory Social Security system
Refusal or inability to provide signed informed consent
According to the investigator, the patient is not eligible for inclusion in the study

Treatment and study plan

RIPH2

Diagnostic Test

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

Primary outcomes

Monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus

Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Perniconi, Dr

CONTACT

[email protected]

0142657831

Sponsors and collaborators

Lead sponsor

CerbaXpert

Other

Registry information

Acronym: CEB Covid-19

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Nov 22, 2023
Registry last updated: Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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