NCT04354766: ANTI-COV-2

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

Completed Last updated 18 June 2021

What this trial tests

trial testing Blood sample in COVID in 10 participants. Completed in 18 May 2020.

Timeline

29 April 2020

Primary endpoint
18 May 2020

18 May 2020

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Completed
Study type	OBSERVATIONAL
Enrollment	10
Start date	29 April 2020
Primary completion	18 May 2020
Estimated completion	18 May 2020
Sites	1 location across France

Drugs / interventions tested

• Blood sample — full drug profile →

Conditions studied

• COVID — all drugs for COVID →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunobiology and immunotherapy of COVID-19: A clinically updated overview.
   Esmaeilzadeh A, Elahi R. · · 2021 · cited 59× · PMID 33022076 · DOI 10.1002/jcp.30076
2. Coronavirus 2019 Disease (COVID-19), Systemic Inflammation, and Cardiovascular Disease.
   Inciardi RM, Solomon SD, Ridker PM, Metra M. · · 2020 · cited 40× · PMID 32677478 · DOI 10.1161/jaha.120.017756
3. SARS-CoV-2: Immune Response Elicited by Infection and Development of Vaccines and Treatments.
   Canedo-Marroquín G, Saavedra F, Andrade CA, Berrios RV, et al · · 2020 · cited 27× · PMID 33362758 · DOI 10.3389/fimmu.2020.569760
4. Immunotherapies and immunomodulatory approaches in clinical trials - a mini review.
   Iqbal Yatoo M, Hamid Z, Rather I, Nazir QUA, et al · · 2021 · cited 23× · PMID 33577374 · DOI 10.1080/21645515.2020.1871295
5. An update to "novel therapeutic approaches for treatment of COVID-19".
   Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2021 · cited 21× · PMID 33392632 · DOI 10.1007/s00109-020-02027-1
6. Immunological perspectives on the pathogenesis, diagnosis, prevention and treatment of COVID-19.
   Ni Y, Alu A, Lei H, Wang Y, et al · · 2021 · cited 20× · PMID 34766001 · DOI 10.1186/s43556-020-00015-y
7. COVID-19: A Review on Diagnosis, Treatment, and Prophylaxis.
   Fierabracci A, Arena A, Rossi P. · · 2020 · cited 16× · PMID 32708112 · DOI 10.3390/ijms21145145
8. Neutralizing and enhancing monoclonal antibodies in SARS-CoV-2 convalescent patients: lessons from early variant infection and impact on shaping emerging variants.
   Coutant F, Touret F, Pin JJ, Alonzo M, et al · · 2024 · cited 4× · PMID 38240255 · DOI 10.1080/22221751.2024.2307510