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

Study Overview
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Brief Summary
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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

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

Conditions
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COVID-19, Immunocompromised Host

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVUSHELD (tixagévimab/cilgavimab) 300 mg<br>Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 300mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. | |
| EVUSHELD (tixagévimab/cilgavimab) 600 mg<br>Patients who may be included in this group are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) of EVUSHELD 600mg. Patient are treated and monitored according to the Therapeutic Use Protocols specific for EVUSHELD defined by the ANSM. In addition to their follow-up planned for usual care (including protocol for ATU), they are invited to participate in the research. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody activity |  | Month 1 | 
| Neutralizing antibody activity |  | Month 2 | 
| Neutralizing antibody activity |  | Month 3 | 
| Neutralizing antibody activity |  | Month 4 | 
| Neutralizing antibody activity |  | Month 5 | 
| Neutralizing antibody activity |  | Month 6 | 
| Neutralizing antibody activity |  | Month 9 | 
| Neutralizing antibody activity |  | Month 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Exposure Prophylaxis, Antibodies Monoclonal, Neutralizing Antibodies