This is a national multicentre observational study with retrospective and prospectivedata collection to assess the time to hospitalisation of patients with a confirmeddiagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonalantibodies.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 AIFAcriteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonalantibodies 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 collectdata on symptoms, possible hospitalization and final clinical outcome (alive withsymptoms, alive without symptoms, alive with symptoms and hospitalized or deceased).Data will be collected using a dedicated electronic Case Report Form (eCRF).
Not Provided
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
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
Asst-Monza Ospedale San Gerardo
Monza, Lombardia, Italy
Investigator: Paolo Bonfanti
Contact: 0392339310
p.bonfanti@asst-monza.it
Paolo Bonfanti, MD
0392339310
paolo.bonfanti@unimib.it
Alessandror Soria, MD
0392339590
a.soria@asst-monza.it
Paolo Bonfanti, MD, Principal Investigator
Asst-Monza Ospedale San Gerardo