Cytokine Release Syndrome in COVID-19-induced PneumoniaNCT04476706
Canakinumab MAP in COVID-19 Pneumonia With CRS
A study testing canakinumab in people with Cytokine Release Syndrome in COVID-19-induced Pneumonia, run by Novartis Pharmaceuticals.
Trial summary
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cytokine Release Syndrome in COVID-19-induced Pneumonia
- What is being tested?
- canakinumab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
Who may be able to join
- Age ≥ 18 years old;
- Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending);
- Hospitalized with COVID-19-induced pneumonia;
- Elevated CRP or ferritin levels;
- Body weight ≥ 40kg.
Who cannot join
- Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;
- On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day);
- Use of tocilizumab within 3 weeks prior to dosing with canakinumab;
- Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);
- Patients with significant neutropenia (ANC <1000/mm3);
- Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) prior to canakinumab dose.
About this study
Official title: Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia
- Being tested
- canakinumab
- Keywords
- canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome
- Medical subject headings
- COVID-19, Coronavirus Infections, Pneumonia, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canakinumabDrug
Also called Ilaris; ACZ885
canakinumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Release Syndrome in COVID-19-induced PneumoniaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476706
- Sponsor's protocol ID
- CACZ885D2001M
- Status last verified
- Jan 2021
- First submitted
- 16 Jul 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managed Access Program (MAP) to Provide Access to Canakinumab Treatment of Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
- ClinicalTrials.gov ID
- NCT04476706
- Acronym / sponsor ID
- CACZ885D2001M
- Keywords
- canakinumab, Ilaris, ACZ885, COVID-19, coronavirus, pneumonia, CRS, cytokine release syndrome
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 20 Jul 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.
This is a global Managed Access Program (MAP) to provide access to canakinumab to patients with cytokine release syndrome resulting from COVID-19 pneumonia
Study design
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old;
- Clinical diagnosis of SARS-CoV-2 virus by PCR, or by other approved diagnostic methodology, or, with presumptive diagnosis of COVID-19 (other respiratory causes ruled out and COVID-19 test pending);
- Hospitalized with COVID-19-induced pneumonia;
- Elevated CRP or ferritin levels;
- Body weight ≥ 40kg.
Key exclusion criteria (6 listed)
- Eligible patients must not have a history of hypersensitivity to any drugs or metabolites of similar chemical classes as canakinumab;
- On the day of canakinumab treatment initiation; treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-17 agents. Immunomodulators (topical or inhaled) for asthma and atopic dermatitis are permitted as are systemic low-dose corticosteroids (e.g. ≤10 mg prednisone per day);
- Use of tocilizumab within 3 weeks prior to dosing with canakinumab;
- Suspected or known active bacterial, fungal, or parasitic infection (besides COVID-19);
- Patients with significant neutropenia (ANC <1000/mm3);
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 |
|---|---|---|
| canakinumabAlso: Ilaris; ACZ885canakinumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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.
Questions about this trial
What is this clinical trial studying?
A study testing canakinumab in people with Cytokine Release Syndrome in COVID-19-induced Pneumonia, run by Novartis Pharmaceuticals.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
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 3 Feb 2021.