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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05268601

Acronym

CONDIVIDIAMO

Enrollment

251

Registered

2022-03-07

Start date

2021-10-14

Completion date

2023-12-22

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

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

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).

Interventions

DRUGBamlanivimab

Administration of monoclonal antibody against SARS-CoV-2

DRUGBamlanivimab and Etesevimab Drug Combination

Combined administration of monoclonal antibodies against SARS-CoV-2

DRUGCasirivimab and Imdevimab Drug Combination

Combined administration of monoclonal antibodies against SARS-CoV-2

DRUGSotrovimab

Administration of monoclonal antibody against SARS-CoV-2

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026