Skip to main content
OpenTrials
Completed

NCT Number: NCT04354766

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de la Croix-Rousse

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • Eurobio Scientific

Registry information

Official study title

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

Acronym: ANTI-COV-2

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.