COVID-19: SARS-CoV-2 Specific Memory B and T-CD4+ Cells

COVID-19 Clinical Trial

— MEMO-COV2  

Official title:

SARS-CoV-2 Specific Memory B and T- CD4+ Cells

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04402892
• Other study ID #: APHP200551
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: MAHEVAS Matthieu, PHD
• Phone: 01 49 81 20 76
• Email: matthieu.mahevas[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

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 .
• 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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years