COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2
NCT ID: NCT05268601
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
251 participants
OBSERVATIONAL
2021-10-14
2023-12-22
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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Bamlanivimab
Administration of monoclonal antibody against SARS-CoV-2
Bamlanivimab and Etesevimab Drug Combination
Combined administration of monoclonal antibodies against SARS-CoV-2
Casirivimab and Imdevimab Drug Combination
Combined administration of monoclonal antibodies against SARS-CoV-2
Sotrovimab
Administration of monoclonal antibody against SARS-CoV-2
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients already hospitalised for non-COVID reason at the time of monoclonal antibody administration
18 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Responsible Party
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Paolo Bonfanti
Director of Infectious Diseases Department
Principal Investigators
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Paolo Bonfanti, MD
Role: PRINCIPAL_INVESTIGATOR
Asst-Monza Ospedale San Gerardo
Locations
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Asst-Monza Ospedale San Gerardo
Monza, Lombardy, Italy
Countries
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Other Identifiers
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MABCOVID01
Identifier Type: -
Identifier Source: org_study_id
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