COVID-19 : Neutralizing Human Monoclonal Antibodies Against SARS-Cov-2 (ANTI-COV-2)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Other: Blood sample

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study relates to 10 adult subjects who were infected with SARS-Cov-2 (positivity confirmed by PCR test), who were symptomatic, and who were in the recovery phase when the blood sample was collected.

Among the 10 convalescent subjects who will be sampled, we will select two distinct populations:

(i) five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform which was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization was not required; (ii) five convalescent patients (minimum 12 days after the onset of symptoms), hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxemic pneumonia requiring hospitalization.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Convalescent patients diagnosed with COVID +; Five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID + on the temporary sampling platform that was set up at HCL at the start of the epidemic, which notably concerns symptomatic healthcare professionals for whom hospitalization does not was not necessary.	Other: Blood sample; This study will require a blood sample (4 ACD tubes, 20 ml) at one time.
Hospitalized convalescent patients diagnosed with COVID +; Five convalescent patients (minimum 12 days after the onset of symptoms), diagnosed COVID +, hospitalized in the infectious diseases department of the Croix-Rousse hospital living in the metropolitan area of Lyon, having presented hypoxaemic pneumonia requiring hospitalization.	Other: Blood sample; This study will require a blood sample (4 ACD tubes, 20 ml) at one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: Eurobio Scientific
• Investigators: Principal Investigator: Frédéric COUTANT, MD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 29, 2020
• Primary Completion (ACTUAL): May 18, 2020
• Study Completion (ACTUAL): May 18, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (ACTUAL): April 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 69HCL20_0340; 2020-A01038-31 (OTHER: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No