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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05216588
Other study ID # ANRS0166s PRECOVIM
Secondary ID 2021-006961-39
Status Recruiting
Phase
First received
Last updated
Start date January 26, 2022
Est. completion date October 30, 2024

Study information

Verified date January 2023
Source ANRS, Emerging Infectious Diseases
Contact Vincent LEVY, MD, PhD
Phone +33 1 48 95 77 33
Email vincent.levy@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective cohort of patients, receiving pre exposure prophylaxis by Anti-SARS-CoV-2 Monoclonal Antibodies, is designed to evaluate the treatment protection against SARS-CoV-2 variants of concerns


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 30, 2024
Est. primary completion date June 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (18 years-old or more) - Patient who received the first administration of Evusheld at 300 mg for less than 4 months and should receive a second dose, according to French recommendations OR Patient scheduled to receive or having received less than a month ago an injection of anti-SARS-CoV-2 monoclonal antibodies, as pre-exposure prophylaxis at 600 mg, according to the French SARS-CoV-2 RT recommendations - qPCR negative at baseline - SARS-CoV-2 RT-qPCR Negative at inclusion - Patients who remain seronegative after a complete COVID-19 vaccination schedule - Immunocompromised patients : Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor - Life expectancy > 3 months - Social security affiliation - Lack of a legal protection measure - Signed informed consent Exclusion Criteria: - Participation to another clinical study - State medical aid - Ongoing or scheduled plasmapheresis or immunoadsorption - Pregnant / lactating woman - Patient whose isolation period is underway following contact with a confirmed case of SARS-CoV2 infection - Hypersensitivity to one of the active substances or to one of the excipients

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Avicenne Bobigny

Sponsors (1)

Lead Sponsor Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

References & Publications (1)

de Lamballerie X, Martin-Blondel G, Dupont A, Izopet J, Mentre F, Kamar N, Autran B, Paintaud G, Caillard S, le Bourgeois A, Richez C, Couzi L, Xhaard A, Marjanovic Z, Avouac J, Jacquet C, Anglicheau D, Cheminant M, Yazdanpanah Y, Guyen SN, Terrier B, Got — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Neutralizing antibody activity Month 1
Primary Neutralizing antibody activity Month 2
Primary Neutralizing antibody activity Month 3
Primary Neutralizing antibody activity Month 4
Primary Neutralizing antibody activity Month 5
Primary Neutralizing antibody activity Month 6
Primary Neutralizing antibody activity Month 9
Primary Neutralizing antibody activity Month 12
Secondary Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection Month 12
Secondary Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period Month 12
Secondary Proportion of patients infected with a resistant variant Month 12
Secondary Proportion of patients with treatment AE Month 12
Secondary Severity of treatment AE Month 12
Secondary Proportion of patients with SAE Month 12
Secondary Proportion of patients with suspended prophylaxis due to adverse event Month 12
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 1
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 2
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 3
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 4
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 5
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 6
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 9
Secondary Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it Month 12
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 1
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 2
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 3
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 4
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 5
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 6
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 9
Secondary Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies Month 12
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 1
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 2
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 3
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 4
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 5
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 6
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 9
Secondary Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2 Month 12
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 1
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 2
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 3
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 4
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 5
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 6
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 9
Secondary Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2 Month 12
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 1
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 2
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 3
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 4
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 5
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 6
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 9
Secondary Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. Month 12
Secondary Anti-S et Anti- N antibodies levels Month 1
Secondary Anti-S et Anti- N antibodies levels Month 2
Secondary Anti-S et Anti- N antibodies levels Month 3
Secondary Anti-S et Anti- N antibodies levels Month 4
Secondary Anti-S et Anti- N antibodies levels Month 5
Secondary Anti-S et Anti- N antibodies levels Month 6
Secondary Anti-S et Anti- N antibodies levels Month 9
Secondary Anti-S et Anti- N antibodies levels Month 12
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