COVID-19, Immunocompromised Host
Conditions
Keywords
Post-Exposure Prophylaxis, Antibodies Monoclonal, Neutralizing Antibodies
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
Interventions
None listed
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody activity | Month 1 |
Secondary
| Measure | 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 |
| 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 |
| Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it | Month 1 |
| 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 risk of infection by the omicron variant of SARS-CoV-2 | Month 1 |
| Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects. | Month 1 |
| Anti-S et Anti- N antibodies levels | Month 1 |
| Proportion of patients with suspended prophylaxis due to adverse event | Month 12 |
Countries
France
Outcome results
None listed