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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bamlanivimab | Drug | Administration of monoclonal antibody against SARS-CoV-2 | ||
| Bamlanivimab and Etesevimab Drug Combination | Drug | Combined administration of monoclonal antibodies against SARS-CoV-2 | ||
| Casirivimab and Imdevimab Drug Combination | Drug | Combined administration of monoclonal antibodies against SARS-CoV-2 | ||
| Sotrovimab | Drug | Administration of monoclonal antibody against SARS-CoV-2 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria), who receive anti-SARS-CoV-2 monoclonal antibodies.
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonfanti, MD | Asst-Monza Ospedale San Gerardo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asst-Monza Ospedale San Gerardo | Monza | Lombardy | 20900 | Italy |
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| 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 |
| 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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| ID | Term |
|---|---|
| C000711749 | bamlanivimab |
| C000717627 | bamlanivimab and etesevimab drug combination |
| C000711751 | casirivimab and imdevimab drug combination |
| C000711967 | sotrovimab |
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