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

Sponsor
University of Milano Bicocca (Other)
Overall Status
Recruiting
CT.gov ID
NCT05268601
Collaborator
(none)
1,000
1
31.5
31.7

Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Anticipated 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 :
Oct 14, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
May 31, 2024

Outcome Measures

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 [0-30 days]

Secondary Outcome Measures

  1. Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days. [0-30 days]

  2. Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days [0-30 days]

  3. Identifying possible predictive factors of hospitalisation [0-30 days]

  4. Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days [0-30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asst-Monza Ospedale San Gerardo Monza Lombardia Italy 20900

Sponsors and Collaborators

  • University of Milano Bicocca

Investigators

  • Principal Investigator: Paolo Bonfanti, MD, Asst-Monza Ospedale San Gerardo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Bonfanti, Director of Infectious Diseases Department, University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT05268601
Other Study ID Numbers:
  • MABCOVID01
First Posted:
Mar 7, 2022
Last Update Posted:
Mar 7, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Paolo Bonfanti, Director of Infectious Diseases Department, University of Milano Bicocca
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 7, 2022