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

NCT05268601 | Completed

• 1 other identifier: MABCOVID01
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Keywords

SARS-CoV-2 infection; Monoclonal Antibodies; Casirivimab; Imdevimab; Bamlanivimab; Etesevimab; Sotrovimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

Bamlanivimab DRUG

Administration of monoclonal antibody against SARS-CoV-2

Bamlanivimab and Etesevimab Drug Combination DRUG

Combined administration of monoclonal antibodies against SARS-CoV-2

Casirivimab and Imdevimab Drug Combination DRUG

Combined administration of monoclonal antibodies against SARS-CoV-2

Sotrovimab DRUG

Administration of monoclonal antibody against SARS-CoV-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria), who receive anti-SARS-CoV-2 monoclonal antibodies.

You may qualify if:

• \>/= 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Asst-Monza Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

bamlanivimab; bamlanivimab and etesevimab drug combination; casirivimab and imdevimab drug combination; sotrovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paolo Bonfanti, MD

  Asst-Monza Ospedale San Gerardo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infectious Diseases Department

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 7, 2022
• Study Start: October 14, 2021
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

IT (1)