SARS CoV 2 InfectionCEB Covid-19NCT06144333
Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine
A study testing RIPH2 in people with SARS CoV 2 Infection, run by CerbaXpert.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- RIPH2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,500 participants
- Where
- No sites listed yet
- Study dates
- 23 Dec 2024to 23 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Patient hospitalized for the pathology concerned
- Pregnant or breastfeeding patient
- Dialysis patient
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- RIPH2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPH2Diagnostic test
- Blood sampling by capillary
- Swab sampling
- Blood sampling by venous punction
- Salivary sample, sputum, expectoration:
| Study group | Role | What they receive |
|---|---|---|
| Observational arm | Other | Not described Receives: Diagnostic Test: RIPH2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start23 Dec 2024 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CerbaXpert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144333
- Sponsor's protocol ID
- 2022-A02195-38
- Acronym
- CEB Covid-19
- Status last verified
- Apr 2024
- First submitted
- 17 Nov 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine
- ClinicalTrials.gov ID
- NCT06144333
- Acronym / sponsor ID
- CEB Covid-19 / 2022-A02195-38
- Conditions
- SARS CoV 2 Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- CerbaXpertUniversity, hospital or other
- Study start
- 23 Dec 2024 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm | Other | Diagnostic Test: RIPH2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Pregnant or breastfeeding patient
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPH2* Blood sampling by capillary * Swab sampling * Blood sampling by venous punction * Salivary sample, sputum, expectoration: | Diagnostic test | Observational arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing RIPH2 in people with SARS CoV 2 Infection, run by CerbaXpert.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Perniconi, Dr (0142657831, bperniconi@cerbaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.