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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 (CONDIVIDIAMO)

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ClinicalTrials.gov Identifier: NCT05268601
Recruitment Status : Recruiting
First Posted : March 7, 2022
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Paolo Bonfanti, University of Milano Bicocca

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).


Condition or disease Intervention/treatment
COVID-19 Drug: Bamlanivimab Drug: Bamlanivimab and Etesevimab Drug Combination Drug: Casirivimab and Imdevimab Drug Combination Drug: Sotrovimab

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : October 14, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05268601


Contacts
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Contact: Paolo Bonfanti, MD 0392339310 paolo.bonfanti@unimib.it
Contact: Alessandror Soria, MD 0392339590 a.soria@asst-monza.it

Locations
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Italy
Asst-Monza Ospedale San Gerardo Recruiting
Monza, Lombardia, Italy, 20900
Contact: Paolo Bonfanti    0392339310    p.bonfanti@asst-monza.it   
Contact: Alessandro Soria, MD    0392339590    a.soria@asst-monza.it   
Sponsors and Collaborators
University of Milano Bicocca
Investigators
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Principal Investigator: Paolo Bonfanti, MD Asst-Monza Ospedale San Gerardo
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Responsible Party: Paolo Bonfanti, Director of Infectious Diseases Department, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT05268601    
Other Study ID Numbers: MABCOVID01
First Posted: March 7, 2022    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paolo Bonfanti, University of Milano Bicocca:
SARS-CoV-2 infection
Monoclonal Antibodies
Casirivimab
Imdevimab
Bamlanivimab
Etesevimab
Sotrovimab
Additional relevant MeSH terms:
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COVID-19
Disease Progression
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Bamlanivimab
Antiviral Agents
Anti-Infective Agents