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

ANRS, Emerging Infectious Diseases149 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

COVID-19 Immunocompromised Host

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Avicenne

Bobigny, France

Outcomes

Primary Outcomes

Neutralizing antibody activity

Time frame: Month 1

Neutralizing antibody activity

Time frame: Month 2

Neutralizing antibody activity

Time frame: Month 3

Neutralizing antibody activity

Time frame: Month 4

Neutralizing antibody activity

Time frame: Month 5

Neutralizing antibody activity

Time frame: Month 6

Neutralizing antibody activity

Time frame: Month 9

Neutralizing antibody activity

Time frame: Month 12

Secondary Outcomes

Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection

Time frame: Month 12

Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period

Time frame: Month 12

Proportion of patients infected with a resistant variant

Time frame: Month 12

Proportion of patients with treatment AE

Time frame: Month 12

Data from ClinicalTrials.gov

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Severity of treatment AE

Time frame: Month 12

Proportion of patients with SAE

Time frame: Month 12

Proportion of patients with suspended prophylaxis due to adverse event

Time frame: Month 12

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 1

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 2

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 3

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 4

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 5

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 6

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 9

Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it

Time frame: Month 12

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 1

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 2

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 3

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 4

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 5

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 6

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 9

Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies

Time frame: Month 12