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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006961-39 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVUSHELD (tixagévimab/cilgavimab) 300 mg | 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 | 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Hemopathy : chronic lymphoid leukemia, non hodgkin's lymphoma, HSCT Transplant recipient : kidney, liver, lungs Patients receiving anti CD20 or others immunosuppressor
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent LEVY, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne | Bobigny | 93000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36216187 | Result | 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. |
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Serum, nasopharyngeal swabs
| 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 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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