COVID-19MEMO-COV2NCT04402892
COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells
A study testing 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) and 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) in people with COVID-19 and SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a major threat to our populations and societies. Hypothesis/Objective The acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection
- What is being tested?
- 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) and 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Mar 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
- Patients who have recovered from CoV-2-SARS
- Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR.
- Adult patient (≥ 18 years old) who has recovered from SARS-CoV-2 i.e. has been free of clinical symptoms for more than 15 days and has not been hospitalized and for less than 6 weeks.
- Patient affiliated to a social security scheme.
- Patients hospitalized for SARS-CoV-2
- Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR.
- Adult patient (≥ 18 years old) with clinical symptoms for more than 3 days and hospitalized.
Who cannot join
- Refusal of the patient to participate in the study.
- Patient under guardianship / curatorship
Trial locations and contacts
No sites are listed yet.
About this study
Official title: SARS-CoV-2 Specific Memory B and T- CD4+ Cells
The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a major threat to our populations and societies.
Hypothesis/Objective The acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads at the level of the population to the reduction of the fraction of the population that can be productively infected and transmit the virus, hence, leading to the diminution of the rate of transmission, a phenomenon called herd immunity. Herd immunity was proposed as a strategy to control the infection. However, it remains difficult to model group immunity given the limited knowledge of the interaction between the host immune system with the virus, whose capacity to evolve in face of a neutralizing response is also not known. It is therefore important to acquire a better knowledge of the immunological memory that ensures the resolution of COVID-19 after SARS-CoV2 infection.
Method To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Being tested
- 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ), 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
- Keywords
- COVID-19, Immunity
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )Other
Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)Other
Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for SARS-CoV-2 | Active comparator | Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months . Receives: Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) |
| Patients who have recovered from CoV-2-SARS | Active comparator | Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months . Receives: Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
Biological blood collection: Blood samples taken in the course of the research will be part of a biological collection To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The recruitment of healed patients will be carried out via the Mondor and Bichat hospitals. After information and obtaining consent at D0 : * the patients will be taken from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). * Inpatients will be drawn from the wards of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). Inpatients will be drawn from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at D21, then at D90 (3 months) for both groups of patients. Patients in both groups will be collected from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at 6 months.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402892
- Sponsor's protocol ID
- APHP200551
- Acronym
- MEMO-COV2
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Publications
Sokal A, Bastard P, Chappert P, Barba-Spaeth G, Fourati S, Vanderberghe A, Lagouge-Roussey P, Meyts I, Gervais A, Bouvier-Alias M, Azzaoui I, Fernandez I, de la Selle A, Zhang Q, Bizien L, Pellier I, Linglart A, Rothenbuhler A, Marcoux E, Anxionnat R, Cheikh N, Leger J, Amador-Borrero B, Fouyssac F, Menut V, Goffard JC, Storey C, Demily C, Mallebranche C, Troya J, Pujol A, Zins M, Tiberghien P, Gray PE, McNaughton P, Sullivan A, Peake J, Levy R, Languille L, Rodiguez-Gallego C, Boisson B, Gallien S, Neven B, Michel M, Godeau B, Abel L, Rey FA, Weill JC, Reynaud CA, Tangye SG, Casanova JL, Mahevas M. Human type I IFN deficiency does not impair B cell response to SARS-CoV-2 mRNA vaccination. J Exp Med. 2023 Jan 2;220(1):e20220258. doi: 10.1084/jem.20220258. Epub 2022 Nov 7.
PubMed 36342455Attias P, Azzaoui I, El Karoui K, de La Selle A, Sokal A, Chappert P, Grimbert P, Fernandez I, Bouvier M, Samson C, Dahmane D, Rieu P, Nizard P, Fourati S, Sakhi H, Mahevas M; Mondor NephroCov Study Group. Immune Responses after a Third Dose of mRNA Vaccine Differ in Virus-Naive versus SARS-CoV-2- Recovered Dialysis Patients. Clin J Am Soc Nephrol. 2022 Jul;17(7):1008-1016. doi: 10.2215/CJN.00830122. Epub 2022 Jun 28.
PubMed 35764393
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 Specific Memory B and T- CD4+ Cells
- ClinicalTrials.gov ID
- NCT04402892
- Acronym / sponsor ID
- MEMO-COV2 / APHP200551
- Conditions
- COVID-19, SARS-CoV-2 Infection
- Keywords
- COVID-19, Immunity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 27 May 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.
The current pandemic caused by the newly identified coronavirus responsible for COVID-19 is a major threat to our populations and societies.
Hypothesis/Objective The acquisition of protective immunity at the level of the individual, either through vaccination or natural resolution of the infection, progressively leads at the level of the population to the reduction of the fraction of the population that can be productively infected and transmit the virus, hence, leading to the diminution of the rate of transmission, a phenomenon called herd immunity. Herd immunity was proposed as a strategy to control the infection. However, it remains difficult to model group immunity given the limited knowledge of the interaction between the host immune system with the virus, whose capacity to evolve in face of a neutralizing response is also not known. It is therefore important to acquire a better knowledge of the immunological memory that ensures the resolution of COVID-19 after SARS-CoV2 infection.
Method To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The recruitment of healed patients will be carried out via the Mondor and Bichat hospitals. After information and obtaining consent at D0 : * the patients will be taken from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). * Inpatients will be drawn from the wards of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes). Inpatients will be drawn from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at D21, then at D90 (3 months) for both groups of patients. Patients in both groups will be collected from the departments of the participating centres (35 ml of blood, 5 LITHIUM HEPARINATE tubes) at 6 months.
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for SARS-CoV-2 | Active comparator | Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months . |
| Patients who have recovered from CoV-2-SARS | Active comparator | Other: 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have recovered from CoV-2-SARS
- Adult patient (≥ 18 years old) with a positive SARS-CoV-2 PCR.
- Adult patient (≥ 18 years old) who has recovered from SARS-CoV-2 i.e. has been free of clinical symptoms for more than 15 days and has not been hospitalized and for less than 6 weeks.
- Patient affiliated to a social security scheme.
- Patients hospitalized for SARS-CoV-2
Key exclusion criteria (2 listed)
- Refusal of the patient to participate in the study.
- Patient under guardianship / curatorship
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 |
|---|---|---|
| 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months . | Other | Patients hospitalized for SARS-CoV-2 |
| 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months . | Other | Patients who have recovered from CoV-2-SARS |
Primary outcome
Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
Time frame: 5 years
Biological blood collection: Blood samples taken in the course of the research will be part of a biological collection To study single-cell B and T memory cells specific for the anti-SARS-CoV-2 response and characterize somatic mutations of immunoglobulin genes and TCR, in hospitalized and symptomatic patients and in patients cured of SARS-CoV-2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 36342455Sokal A, Bastard P, Chappert P, Barba-Spaeth G, Fourati S, Vanderberghe A, Lagouge-Roussey P, Meyts I, Gervais A, Bouvier-Alias M, Azzaoui I, Fernandez I, de la Selle A, Zhang Q, Bizien L, Pellier I, Linglart A, Rothenbuhler A, Marcoux E, Anxionnat R, Cheikh N, Leger J, Amador-Borrero B, Fouyssac F, Menut V, Goffard JC, Storey C, Demily C, Mallebranche C, Troya J, Pujol A, Zins M, Tiberghien P, Gray PE, McNaughton P, Sullivan A, Peake J, Levy R, Languille L, Rodiguez-Gallego C, Boisson B, Gallien S, Neven B, Michel M, Godeau B, Abel L, Rey FA, Weill JC, Reynaud CA, Tangye SG, Casanova JL, Mahevas M. Human type I IFN deficiency does not impair B cell response to SARS-CoV-2 mRNA vaccination. J Exp Med. 2023 Jan 2;220(1):e20220258. doi: 10.1084/jem.20220258. Epub 2022 Nov 7.
- Derived from this study: PubMed 35764393Attias P, Azzaoui I, El Karoui K, de La Selle A, Sokal A, Chappert P, Grimbert P, Fernandez I, Bouvier M, Samson C, Dahmane D, Rieu P, Nizard P, Fourati S, Sakhi H, Mahevas M; Mondor NephroCov Study Group. Immune Responses after a Third Dose of mRNA Vaccine Differ in Virus-Naive versus SARS-CoV-2- Recovered Dialysis Patients. Clin J Am Soc Nephrol. 2022 Jul;17(7):1008-1016. doi: 10.2215/CJN.00830122. Epub 2022 Jun 28.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Related trials for COVID-19
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
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.
Questions about this trial
What is this clinical trial studying?
A study testing 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients ) and 35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients) in people with COVID-19 and SARS-CoV-2 Infection, run by Assistance Publique - Hôpitaux de Paris.
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 7 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 27 May 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 MAHEVAS Matthieu, PHD (01 49 81 20 76, matthieu.mahevas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological memory: resolution of COVID-19 after SARS-CoV2 infection. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04402892, which also lists 2 linked publications.
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 27 May 2020.