Canakinumab MAP in COVID-19 Pneumonia With CRS

NCT04476706 | Unknown

• 1 other identifier: CACZ885D2001M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cytokine Release Syndrome in COVID-19-induced Pneumonia

Keywords

canakinumab; Ilaris; ACZ885; COVID-19; coronavirus; pneumonia; CRS; cytokine release syndrome

Interventions

canakinumab DRUG

canakinumab

Also known as: Ilaris; ACZ885

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Pneumonia; Cytokine Release Syndrome

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01