COVID-19CONDIVIDIAMONCT05268601
COVID-19 and Disease Progression to the Severe Form: a Study on the Use of Monoclonal Antibodies Against SARS-CoV-2
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Bamlanivimab, Bamlanivimab and Etesevimab Drug Combination and Casirivimab and Imdevimab Drug Combination
- How many people
- 251 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2021to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- >/= 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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).
- Conditions
- COVID-19
- Being tested
- Bamlanivimab, Bamlanivimab and Etesevimab Drug Combination, Casirivimab and Imdevimab Drug Combination, Sotrovimab
- Keywords
- SARS-CoV-2 infection, Monoclonal Antibodies, Casirivimab, Imdevimab, Bamlanivimab, Etesevimab, Sotrovimab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BamlanivimabDrug
Administration of monoclonal antibody against SARS-CoV-2
Bamlanivimab and Etesevimab Drug CombinationDrug
Combined administration of monoclonal antibodies against SARS-CoV-2
Casirivimab and Imdevimab Drug CombinationDrug
Combined administration of monoclonal antibodies against SARS-CoV-2
SotrovimabDrug
Administration of monoclonal antibody against SARS-CoV-2
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-30 days
Secondary outcomes (4)
Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.
Measured: 0-30 days
Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days
Measured: 0-30 days
Identifying possible predictive factors of hospitalisation
Measured: 0-30 days
Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start14 Oct 2021
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonfanti, University of Milano Bicocca
- Investigators
- Paolo Bonfanti, MD, Principal investigator, Asst-Monza Ospedale San Gerardo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268601
- Sponsor's protocol ID
- MABCOVID01
- Acronym
- CONDIVIDIAMO
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05268601
- Acronym / sponsor ID
- CONDIVIDIAMO / MABCOVID01
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2 infection, Monoclonal Antibodies, Casirivimab, Imdevimab, Bamlanivimab, Etesevimab, Sotrovimab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- >/= 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BamlanivimabAdministration of monoclonal antibody against SARS-CoV-2 | Drug | – |
| Bamlanivimab and Etesevimab Drug CombinationCombined administration of monoclonal antibodies against SARS-CoV-2 | Drug | – |
| Casirivimab and Imdevimab Drug CombinationCombined administration of monoclonal antibodies against SARS-CoV-2 | Drug | – |
| SotrovimabAdministration of monoclonal antibody against SARS-CoV-2 | Drug | – |
Primary outcome
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
4 secondary outcomes
Estimating the COVID-19 lethality rate in patients receiving monoclonal antibodies (mAb) at 30 days.
Time frame: 0-30 days
Describing the evolution of COVID-19 symptoms in patients receiving mAb up to 30 days
Time frame: 0-30 days
Identifying possible predictive factors of hospitalisation
Time frame: 0-30 days
Describing the clinical progression of patients receiving casirivimab/imdevimab while hospitalized up to 30 days
Time frame: 0-30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Bonfanti, MD principal investigator
Asst-Monza Ospedale San Gerardo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 0-30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.