Clinical trial NCT05216588: Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort.
Official title: Pre-exposure Prophylaxis of SARS-CoV-2 Infection (COVID-19) by Monoclonal Antibodies with Early Access Authorization in Immunocompromised Patients. a Prospective Cohort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Immunocompromised Host
Keywords: Post-Exposure Prophylaxis
Antibodies Monoclonal
Neutralizing Antibodies
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2022-01-31
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who may be included in the cohort are patients eligible for prophylaxis treatments for COVID-19, under a cohort Temporary Authorization for Use (ATUc) or full market approval. In case of ATUc, patient are treated and monitored according to the Therapeutic Use Protocols specific for each ATU treatment 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Neutralizing antibody activity
timeFrame: Month 1
measure: Neutralizing antibody activity
timeFrame: Month 2
measure: Neutralizing antibody activity
timeFrame: Month 3
measure: Neutralizing antibody activity
timeFrame: Month 4
measure: Neutralizing antibody activity
timeFrame: Month 5
measure: Neutralizing antibody activity
timeFrame: Month 6
measure: Neutralizing antibody activity
timeFrame: Month 9
measure: Neutralizing antibody activity
timeFrame: Month 12
Secondary outcomes:
measure: Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR) and symptoms of SARS-CoV-2 infection
timeFrame: Month 12
measure: Proportion of subjects hospitalized related to a RT-qPCR confirmed SARS-CoV-2 infection during prophylaxis period
timeFrame: Month 12
measure: Proportion of patients infected with a resistant variant
timeFrame: Month 12
measure: Proportion of patients with treatment AE
timeFrame: Month 12
measure: Severity of treatment AE
timeFrame: Month 12
measure: Proportion of patients with SAE
timeFrame: Month 12
measure: Proportion of patients with suspended prophylaxis due to adverse event
timeFrame: Month 12
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 1
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 2
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 3
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 4
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 5
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 6
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 9
measure: Variability of the individual pharmacokinetic parameters of the two monoclonal antibodies and covariates influencing it
timeFrame: Month 12
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 1
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 2
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 3
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 4
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 5
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 6
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 9
measure: Relations between the concentrations of the two monoclonal antibodies and the levels of anti-S and anti-N antibodies
timeFrame: Month 12
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 1
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 2
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 3
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 4
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 5
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 6
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 9
measure: Relations between the concentrations of the two monoclonal antibodies and the neutralizing activity of the serum towards the omicron variant of SARS-CoV-2
timeFrame: Month 12
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 1
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 2
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 3
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 4
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 5
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 6
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 9
measure: Relations between the concentrations of the two monoclonal antibodies and the risk of infection by the omicron variant of SARS-CoV-2
timeFrame: Month 12
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 1
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 2
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 3
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 4
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 5
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 6
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 9
measure: Relationship between the concentrations of the two monoclonal antibodies and the risk of of adverse effects.
timeFrame: Month 12
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 1
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 2
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 3
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 4
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 5
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 6
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 9
measure: Anti-S et Anti- N antibodies levels
timeFrame: Month 12
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Vincent LEVY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Gottenberg JE, Besson C, Letrou S, Kali S, Angoulvant D, Sanchez VP, Tardivon C, Blancho G, Levy V. Low serum neutralization of Omicron variants a month after AZD7442 prophylaxis initiation. J Infect. 2023 Jan;86(1):66-117. doi: 10.1016/j.jinf.2022.10.006. Epub 2022 Oct 8. No abstract available.