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

NCT05268601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 251

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Paolo Bonfanti, MD · Asst-Monza Ospedale San Gerardo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-12-22
Completion
2023-12-22

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05268601 on ClinicalTrials.gov