COVID-19NCT04348448
Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia
An observational study of COVID-19, run by AUSL Romagna Rimini at 1 site in Italy.
Trial summary
The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Canakinumab 150 MG/ML [Ilaris]
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 1 Sep 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with COVID 19
Who may be able to join
- patients with COVID 19 who have received or are candidates to receive treatment with canakinumab subcutaneously
- Age> 18 years
- Pneumonia diagnosed with Chest X-ray / or Chest CT
Who cannot join
- Patients with Covid19-related pathology in the context of another cause of major admission (trauma, surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Use of Canakinumab Administered Subcutaneously in the Treatment of Patients With COVID-19 Pneumonia
The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously.
- Conditions
- COVID-19
- Being tested
- Canakinumab 150 MG/ML [Ilaris]
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canakinumab 150 MG/ML [Ilaris]Drug
COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care treatment
percentage of patients treated with canakinumab sc who do not require intensive care treatment during hospitalization for COVID-19
Measured: 9 months
Secondary outcomes (4)
ICU stay times
ICU stay times
Measured: 9 months
% died after 1 month after treatment
percentage of patients who died 1 month after treatment
Measured: 9 months
hospitalization
time of hospitalization
Measured: 9 months
adverse event
number of adverse event
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Feb 2020
- Primary completion1 May 2020
- Study completion1 Sep 2020
Why it stopped: due to covid
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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348448
- Sponsor's protocol ID
- CANASCOV
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Use of Canakinumab Administered Subcutaneously in the Treatment of Patients With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04348448
- Acronym / sponsor ID
- CANASCOV
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to covid
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Apr 2020 (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.
The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with COVID 19
Key inclusion criteria (3 listed)
- patients with COVID 19 who have received or are candidates to receive treatment with canakinumab subcutaneously
- Age> 18 years
- Pneumonia diagnosed with Chest X-ray / or Chest CT
Key exclusion criteria (1 listed)
- Patients with Covid19-related pathology in the context of another cause of major admission (trauma, surgery)
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 |
|---|---|---|
| Canakinumab 150 MG/ML [Ilaris]COVID-19 | Drug | – |
Primary outcome
intensive care treatment
Time frame: 9 months
percentage of patients treated with canakinumab sc who do not require intensive care treatment during hospitalization for COVID-19
4 secondary outcomes
ICU stay times
Time frame: 9 months
% died after 1 month after treatment
Time frame: 9 months
hospitalization
Time frame: 9 months
adverse event
Time frame: 9 months
Results and safety
The study was stopped early (reason given: due to covid). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 AUSL Romagna Rimini 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 21 Jul 2023. 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 was stopped early (reason given: due to covid). Results are not available in the source record.
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?
intensive care treatment (time frame: 9 months). 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 21 Jul 2023.