COVID-19 and Disease Progression to the Severe Form: A Study on the Use of Monoclonal Antibodies Against SARS-CoV-2

Study Overview
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Brief Summary
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This is a national multicentre observational study with retrospective and prospective data collection to assess the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies. The subjects enrolled will be patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonal antibodies because of negative serology (according to AIFA criteria). It is estimated to enrol about 1000 subjects. Patients will be evaluated at enrollment and 28 days following administration to collect data on symptoms, possible hospitalization and final clinical outcome (alive with symptoms, alive without symptoms, alive with symptoms and hospitalized or deceased). Data will be collected using a dedicated electronic Case Report Form (eCRF).

Official Title
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COVID-19 and Disease Progression to the Severe Form: a Multicentre Observational Study on the Use of Monoclonal Antibodies Against SARS-CoV-2 in Outpatients and Inpatients

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Bamlanivimab
* Drug: Bamlanivimab and Etesevimab Drug Combination
* Drug: Casirivimab and Imdevimab Drug Combination
* Drug: Sotrovimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18 years Confirmed diagnosis of SARS-CoV-2 infection Having received or receiving any anti-SARS-CoV-2 monoclonal antibody (or combination of monoclonal antibodies) prescribed through the AIFA registry Signature of informed consent (for subjects enrolled in the prospective part) Exclusion Criteria: Absence of criteria for prescribing monoclonal antibodies as determined by AIFA Patients already hospitalised for non-COVID reason at the time of monoclonal antibody administration

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

| Intervention/Treatment |
| --- |
|Drug: Bamlanivimab|Administration of monoclonal antibody against SARS-CoV-2|
|Drug: Bamlanivimab and Etesevimab Drug Combination|Combined administration of monoclonal antibodies against SARS-CoV-2|
|Drug: Casirivimab and Imdevimab Drug Combination|Combined administration of monoclonal antibodies against SARS-CoV-2|
|Drug: Sotrovimab|Administration of monoclonal antibody against SARS-CoV-2|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimating the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies up to 30 days |  | 0-30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days. |  | 0-30 days | 
| Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days |  | 0-30 days | 
| Identifying possible predictive factors of hospitalisation |  | 0-30 days | 
| Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days |  | 0-30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 infection, Monoclonal Antibodies, Casirivimab, Imdevimab, Bamlanivimab, Etesevimab, Sotrovimab