COVID-19 : Neutralizing Human Monoclonal Antibodies Against SARS-Cov-2

COVID Clinical Trial

— ANTI-COV-2  

Official title:

Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354766
• Other study ID #: 69HCL20_0340
• Secondary ID: 2020-A01038-31
• Status: Completed
• Start date: April 29, 2020
• Est. completion date: May 18, 2020

Study information

• Verified date: June 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale : The emergence of the novel, pathogenic SARS-coronavirus 2 (SARS-CoV-2) threatens public health. To date, there are no effective drug option to prevent the infection, nor therapeutics for controlling the deadly COVID-19. However, the majority of patients infected with SARS-Cov-2 eliminate the virus by mounting a protective antiviral immune response, associated in particular with the production of neutralizing antibodies. Neutralizing antibodies could be of particular interest for therapeutic purposes, but also for preventive applications, to protect people who have never been in contact with the virus, or immunocompromised patients.

The objectives of this study are :

• To generate human monoclonal antibodies neutralizing SARS-Cov-2 from immortalized B cells of convalescent patients.

• To compare the serological profiles between convalescent patients that develop mild or uncomplicated illness and convalescent patients that develop a more severe disease, that required hospitalization and oxygen support.

• To compare for each patient the neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Patient who signed the study consent form

• Convalescent patient (at least 12 days after the onset of symptoms), having been sampled at Hospices Civils de Lyon for a suspected infection with SARS-Cov-2, confirmed by PCR.

Exclusion Criteria:

• Patient treated with rituximab

• Patient treated with immunoglobulins

• Patient over 18 years old, subject to a legal protection measure (guardianship or trusteeship)

• Patient deprived of liberty

• Pregnant or lactating woman

• Patient not affiliated to a social security scheme or beneficiary of a similar scheme.

Related Conditions & MeSH terms

• COVID

Intervention

Other:
• Blood sample
This study will require a blood sample (4 ACD tubes, 20 ml) at one time.

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Eurobio Scientific

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.	Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.	3 weeks