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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354766
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Eurobio Scientific
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment
COVID Other: Blood sample

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Generation of Human Monoclonal Antibodies Neutralizing SARS-Cov-2 From B Cells of Convalescent Patients
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

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.




Primary Outcome Measures :
  1. Production of several human monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2. [ Time Frame: 3 weeks ]
    Isolation of immortalized B lymphocyte clones, producer of monoclonal antibodies capable of neutralizing the infection of a target cell by SARS-COV-2.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354766


Contacts
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Contact: Frédéric COUTANT, MD 04-78-86-10-48 ext +33 frederic.coutant@chu-lyon.fr

Locations
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France
Hôpital de la Croix-Rousse Recruiting
Lyon, France
Contact: Tristan FERRY, MD    04.72.07.11.07 ext +33    tristan.ferry@chu-lyon.fr   
Principal Investigator: Tristan FERRY, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Eurobio Scientific
Investigators
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Principal Investigator: Frédéric COUTANT, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04354766    
Other Study ID Numbers: 69HCL20_0340
2020-A01038-31 ( Other Identifier: ID-RCB )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No