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

Completed

• Conditions: COVID-19

• Registration Number: NCT05268601
• Lead Sponsor: University of Milano Bicocca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-07
• Primary Completion: 2023-12-22
• Study Completion: 2023-12-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Asst-Monza Ospedale San Gerardo; 🇮🇹 Monza, Lombardia, Italy