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NCT Number: NCT05268601

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

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).

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asst-Monza Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: 0-30 days

Secondary outcomes

  1. Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.

    Time frame: 0-30 days

  2. Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days

    Time frame: 0-30 days

  3. Identifying possible predictive factors of hospitalisation

    Time frame: 0-30 days

  4. Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days

    Time frame: 0-30 days

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study 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

Acronym: CONDIVIDIAMO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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