Clinical trial NCT05268601: COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: SARS-CoV-2 infection
Monoclonal Antibodies
Casirivimab
Imdevimab
Bamlanivimab
Etesevimab
Sotrovimab
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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).


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 0-30 days
Secondary outcomes:
measure: Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.
timeFrame: 0-30 days
measure: Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days
timeFrame: 0-30 days
measure: Identifying possible predictive factors of hospitalisation
timeFrame: 0-30 days
measure: Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Asst-Monza Ospedale San Gerardo
state: Lombardia
Study officials:
affiliation: Asst-Monza Ospedale San Gerardo
name: Paolo Bonfanti, MD
role: PRINCIPAL_INVESTIGATOR
References: