NCT05268601

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 251 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-14
• Primary completion: 2023-12-22
• Completion: 2023-12-22
• First posted: 2022-03-07
• Last updated: 2025-03-30

Locations

1 site across 1 country: Italy