COVID-19COVERTNCT06862531
A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.
A study testing blood sample in people with COVID-19, run by Bioaster at 1 site in France.
Trial summary
The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2020to 17 Nov 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old,
- Patient whose Covid-19 diagnosis has been confirmed by RT-PCR test (SARS-CoV-2 positive) from a nasopharyngeal swab/broncho alveolar lavage
- Patient whose severity of Covid-19 required hospital treatment
- Patient whose Covid-19 form is defined as moderate (stay in general ward) or severe (stay in ICU), based on the clinical evaluation conducted by the doctor
- Patient agreeing to participate in the study and having signed the informed consent.
Who cannot join
- Adult person subject to legal protection,
- Pregnant, parturient or breastfeeding woman
- Person not affiliated to a social security scheme or not beneficiary of such a scheme
- Person subject to a safeguard measure
- Person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under Articles L.3212-1 and 3213-1, which do not fall under Article L.1122-8 of the Public Health Code.
Trial locations and contacts
1 site in 1 country.
France1 site
CH ANnecy-GEnevois (CHANGE)
Metz-Tessy, Auvergne-Rhône-Alpes, 74370
About this study
Official title: COVERT : A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.
The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.
- Conditions
- COVID-19
- Being tested
- blood sample
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
A sample of blood (1mL) was taken
| Study group | Role | What they receive |
|---|---|---|
| Severe | Other | patients who developed a severe form of Covid (hospitalized in ICU in March/April 2020) Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)
The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)
Measured: 10month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start25 Sep 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862531
- Sponsor's protocol ID
- 2020-A02008-31
- Acronym
- COVERT
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVERT : A Single-center, Interventional Diagnostic Study With Minimal Risks and Constraints, Aimed at Longitudinally Evaluating Serum Antibody Levels in Patients With COVID-19 According to the Severity of Their Symptoms.
- ClinicalTrials.gov ID
- NCT06862531
- Acronym / sponsor ID
- COVERT / 2020-A02008-31
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BioasterUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 6 Mar 2025 (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.
The COVERT protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with COVID-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe | Other | Biological: blood samplepatients who developed a severe form of Covid (hospitalized in ICU in March/April 2020) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old,
- Patient whose Covid-19 diagnosis has been confirmed by RT-PCR test (SARS-CoV-2 positive) from a nasopharyngeal swab/broncho alveolar lavage
- Patient whose severity of Covid-19 required hospital treatment
- Patient whose Covid-19 form is defined as moderate (stay in general ward) or severe (stay in ICU), based on the clinical evaluation conducted by the doctor
- Patient agreeing to participate in the study and having signed the informed consent.
Key exclusion criteria (5 listed)
- Adult person subject to legal protection,
- Pregnant, parturient or breastfeeding woman
- Person not affiliated to a social security scheme or not beneficiary of such a scheme
- Person subject to a safeguard measure
- Person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under Articles L.3212-1 and 3213-1, which do not fall under Article L.1122-8 of the Public Health Code.
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 |
|---|---|---|
| blood sampleA sample of blood (1mL) was taken | Biological | Severe |
Primary outcome
The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)
Time frame: 10month after inclusion
The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form)
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 6 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with COVID-19, run by Bioaster 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 5 inclusion and 5 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 6 Mar 2025. 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?
The correlation between serum antibody levels (IgM/IgG), the stage of the disease (in relation to the onset date of symptoms), and the severity of the disease (severe form versus moderate form) (time frame: 10month after inclusion). 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 6 Mar 2025.