Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort.

Completed

• Conditions: Immunocompromised Host; COVID-19

• Registration Number: NCT05216588
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-25
• Study Start: 2022-01-26
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-01-31
• Primary Completion: 2023-11-03
• Study Completion: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody activity	Month 12

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with SAE	Month 12
Proportion of patients with suspended prophylaxis due to adverse event	Month 12
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
Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.	Month 12
Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period	Month 12
Proportion of patients with treatment AE	Month 12
Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection	Month 12
Severity of treatment AE	Month 12
Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies	Month 12
Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2	Month 12
Anti-S et Anti- N antibodies levels	Month 12
Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it	Month 12
Proportion of patients infected with a resistant variant	Month 12

Trial Locations

Locations (1)

Hôpital Avicenne; 🇫🇷 Bobigny, France