COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells (MEMO-COV2)
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
Sponsored by
About this trial
This is an interventional basic science trial for COVID-19 focused on measuring COVID-19, Immunity
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal of the patient to participate in the study.
- Patient under guardianship / curatorship
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients hospitalized for SARS-CoV-2
Patients who have recovered from CoV-2-SARS
Arm Description
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 will be sampled at inclusion (Day 0), at 3 months and at 6 months .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04402892
First Posted
May 19, 2020
Last Updated
May 25, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04402892
Brief Title
COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells
Acronym
MEMO-COV2
Official Title
SARS-CoV-2 Specific Memory B and T- CD4+ Cells
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Infection
Keywords
COVID-19, Immunity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients hospitalized for SARS-CoV-2
Arm Type
Active Comparator
Arm Description
Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .
Arm Title
Patients who have recovered from CoV-2-SARS
Arm Type
Active Comparator
Arm Description
Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
Intervention Type
Other
Intervention Name(s)
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )
Intervention Description
Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .
Intervention Type
Other
Intervention Name(s)
35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)
Intervention Description
Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
Primary Outcome Measure Information:
Title
Immunological memory: resolution of COVID-19 after SARS-CoV2 infection.
Description
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.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Refusal of the patient to participate in the study.
Patient under guardianship / curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MAHEVAS Matthieu, PHD
Phone
01 49 81 20 76
Email
matthieu.mahevas@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Citations:
PubMed Identifier
35764393
Citation
Attias 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.
Results Reference
derived
Learn more about this trial
COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells
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