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

April 12, 2024 updated by: CerbaXpert

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CerbaXpert

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 23, 2024

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

November 23, 2026

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A02195-38

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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