Official Title
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
Brief Summary

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).

Detailed Description

Not Provided

Unknown status
COVID-19

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

Asst-Monza Ospedale San Gerardo
Monza, Lombardia, Italy

Investigator: Paolo Bonfanti
Contact: 0392339310
p.bonfanti@asst-monza.it

Contacts

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

University of Milano Bicocca
NCT Number
Keywords
SARS-CoV-2 infection
Monoclonal antibodies
casirivimab
Imdevimab
bamlanivimab
Etesevimab
sotrovimab
MeSH Terms
COVID-19
Disease Progression
Sotrovimab
Bamlanivimab
Casirivimab and imdevimab drug combination