Covid19COVID-TESTNCT04467008
Covid-19 Rapid Diagnostic Tests on Blood Drop
An observational study of Covid19, run by CMC Ambroise Paré at 1 site in France.
Trial summary
This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 15 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed COVID-19 pneumonia (using RT-PCR) who required hospitalization in intensive care unit.
Who may be able to join
- Confirmed COVID-19 diagnosis with at least one positive RT-PCR
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop
This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.
Read the detailed description
The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.
Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).
As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.
- Conditions
- Covid19
- Keywords
- Covid 19, Diagnostic, Biosynex, Blood drop
- Medical subject headings
- COVID-19, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One group of patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity of the rapid diagnostic test
Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG
Measured: Immediate, up to 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Nguyen, MD, Principal investigator, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467008
- Sponsor's protocol ID
- 2020/05
- Acronym
- COVID-TEST
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop
- ClinicalTrials.gov ID
- NCT04467008
- Acronym / sponsor ID
- COVID-TEST / 2020/05
- Conditions
- Covid19
- Keywords
- Covid 19, Diagnostic, Biosynex, Blood drop
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 10 Jul 2020 (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.
This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.
Detailed description
The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.
Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).
As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group of patients | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed COVID-19 pneumonia (using RT-PCR) who required hospitalization in intensive care unit.
Key inclusion criteria (1 listed)
- Confirmed COVID-19 diagnosis with at least one positive RT-PCR
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positivity of the rapid diagnostic test
Time frame: Immediate, up to 1 day.
Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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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. This study is not recruiting at the moment.
Lee Nguyen, MD principal investigator
CMC Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by CMC Ambroise Paré at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positivity of the rapid diagnostic test (time frame: Immediate, up to 1 day.). 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 10 Nov 2020.