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

COVID-19 Clinical Trial

— CONDIVIDIAMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05268601
• Other study ID #: MABCOVID01
• Status: Recruiting
• Start date: October 14, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2022
• Source: University of Milano Bicocca
• Contact: Paolo Bonfanti, MD
• Phone: 0392339310
• Email: paolo.bonfanti[@]unimib.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Disease Progression

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Italy	Asst-Monza Ospedale San Gerardo	Monza	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.		0-30 days
Secondary	Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days		0-30 days
Secondary	Identifying possible predictive factors of hospitalisation		0-30 days
Secondary	Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days		0-30 days