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

NCT ID: NCT06144333

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 7500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-23
• Study Completion Date: 2026-11-23

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.

Conditions

SARS CoV 2 Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Observational arm

Group Type: OTHER

RIPH2

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

RIPH2

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CerbaXpert

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Barbara Perniconi, Dr

Role: CONTACT

bperniconi@cerbaresearch.com

0142657831

Other Identifiers

2022-A02195-38

Identifier Type: -

Identifier Source: org_study_id