Covid19PANCOLINNCT04543006
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
A study testing serology in people with Covid19, run by University Hospital, Grenoble.
Trial summary
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2020to 31 Dec 2021
- 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
- positive SARS-CoV-2
Who cannot join
- age under 18
- immunocompromised at the onset of Covid-19
Trial locations and contacts
No sites are listed yet.
About this study
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.
The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.
The investigators will determine whether this persistance varies according to
- the severity of the Covid-19
- a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.
Read the detailed description
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.
The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.
The investigators will determine whether this persistance varies according to
- the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more)
- a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.
- Conditions
- Covid19
- Being tested
- serology
- Keywords
- neutralizing antibodies, long-term persistence
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serologyDiagnostic test
blood sample of 10 ml twice (6 and 12 months after the Covid-19)
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 | Other | only arm: Covid-19 proven by PCR Receives: Diagnostic Test: serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-SARS-CoV-2 neutralizing antibody titers
Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start8 Sep 2020 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- sample of patients 6 and 12 months after the acute disease
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Epaulard, MD,PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543006
- Sponsor's protocol ID
- EssaiClinique_PANCOLIN
- Acronym
- PANCOLIN
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
- ClinicalTrials.gov ID
- NCT04543006
- Acronym / sponsor ID
- PANCOLIN / EssaiClinique_PANCOLIN
- Conditions
- Covid19
- Keywords
- neutralizing antibodies, long-term persistence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 8 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Sep 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.
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.
The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.
The investigators will determine whether this persistance varies according to
- the severity of the Covid-19
- a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.
Detailed description
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.
The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.
The investigators will determine whether this persistance varies according to
- the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more)
- a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- sample of patients 6 and 12 months after the acute disease
| Arm | Type | Receives |
|---|---|---|
| Covid-19 | Other | Diagnostic Test: serologyonly arm: Covid-19 proven by PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- positive SARS-CoV-2
Key exclusion criteria (2 listed)
- age under 18
- immunocompromised at the onset of Covid-19
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 |
|---|---|---|
| serologyblood sample of 10 ml twice (6 and 12 months after the Covid-19) | Diagnostic test | Covid-19 |
Primary outcome
anti-SARS-CoV-2 neutralizing antibody titers
Time frame: 1 day
Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Olivier Epaulard, MD,PhD principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
A study testing serology in people with Covid19, run by University Hospital, Grenoble.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Epaulard, MD,PhD (0033476765291, oepaulard@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-SARS-CoV-2 neutralizing antibody titers (time frame: 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 16 Sep 2020.