A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies

Study Overview
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Brief Summary
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Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).

Official Title
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A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19

Conditions
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Immunocompromised Patients

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥ 18 years old Patients who received at least one administration of the following therapies: casirivimab-imdevimab, bamlanivimab-etesevimab, tixagevimab-cilgavimab, regdanvimab, sotrovimab or adintrevimab Exclusion Criteria: Patients opposed to the collection of their personal data

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 |
| --- | --- |
| Patients who have received an anti-SARS-CoV-2 monoclonal antibody<br>Patients who have received an anti-SARS-CoV-2 monoclonal antibody, either prophylactically or curatively. | Other: Data collection<br>* Anti SARS-CoV-2 Monoclonal Antibodies: casirivimab-imdevimab (Ronapreve) OR bamlanivimab-etesevimab OR tixagevimab-cilgavimab (Evusheld) OR regdanvimab OR sotrovimab (Xevudy) OR adintrevimab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | Covid-19 mortality : Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies | 29 days after last administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations rate | Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis | 29 days after last administration | 
| Mortality rate | Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis | 29 days after last administration | 
| Hospitalizations rate | Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis | 90 days after last administration | 
| Mortality rate | Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in prophylaxis | 90 days after last administration | 
| Hospitalizations rate | Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing | 29 days after last administration | 
| Mortality rate | Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing | 29 days after last administration | 
| Hospitalizations rate | Explore the hospitalizations rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing | 90 days after last administration | 
| Mortality rate | Explore the mortality rate related to COVID-19 in patients treated with anti-SARS-CoV-2 monoclonal antibodies in healing | 90 days after last administration | 
| Proportion of hospitalizations | Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies | 29 days after last administration | 
| Proportion of deaths | Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies | 29 days after last administration | 
| Proportion of hospitalizations | Proportion of hospitalizations from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies | 90 days after last administration | 
| Proportion of deaths | Proportion of deaths from all causes, in patients treated prophylactically and curatively by anti-SARS-CoV-2 monoclonal antibodies | 90 days after last administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, SARS-CoV-2, Immunocompromised, Monoclonal Antibodies, Mortality