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

NCT06144333 | Not Yet Recruiting

• 1 other identifier: 2022-A02195-38
• Study Type: interventional
• Target: 7,500
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  24 months

Study Arms (1)

Observational arm

OTHER

Diagnostic Test: RIPH2

Interventions

RIPH2 DIAGNOSTIC_TEST

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

Observational arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CerbaXpert: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Barbara Perniconi, Dr

CONTACT

0142657831; bperniconi@cerbaresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 22, 2023
• Study Start: December 23, 2024
• Primary Completion: December 10, 2025
• Study Completion (Estimated): November 23, 2026
• Last Updated: April 15, 2024

Record last verified: 2024-04