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

University of Milano Bicocca

Status: Completed

Conditions: COVID-19

Treatments: Drug: Bamlanivimab; Drug: Bamlanivimab and Etesevimab Drug Combination; Drug: Sotrovimab; Drug: Casirivimab and Imdevimab Drug Combination

Study type: Observational

Funder types: Other

Identifiers

NCT05268601

MABCOVID01

Details and patient eligibility

About

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).

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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