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

Sponsor

CerbaXpert (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06144333

Collaborator

(none)

7,500

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection	Diagnostic Test: RIPH2	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Dec 23, 2023

Anticipated Primary Completion Date :

Dec 10, 2025

Anticipated Study Completion Date :

Nov 23, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Observational arm	Diagnostic Test: RIPH2 Blood sampling by capillary Swab sampling Blood sampling by venous punction Salivary sample, sputum, expectoration:

Arm

Intervention/Treatment

Other: Observational arm

Diagnostic Test: RIPH2

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

Outcome Measures

Primary Outcome Measures

Monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

CerbaXpert

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CerbaXpert

ClinicalTrials.gov Identifier:

NCT06144333

Other Study ID Numbers:

2022-A02195-38

First Posted:

Nov 22, 2023

Last Update Posted:

Nov 22, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Nov 22, 2023