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Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia (CAN-COVID)

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ClinicalTrials.gov Identifier: NCT04362813
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in adult patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

Condition or disease Intervention/treatment Phase
Covid-19 Drug: Canakinumab Drug: Placebo Phase 3

Detailed Description:

This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS). The study will enroll patients to canakinumab or placebo, in addition to standard of care (SOC) per local practice, which may include anti-viral treatment, corticosteroids and/or supportive care.

Patients who meet the inclusion/exclusion criteria will be randomized in a 1:1 ratio to either canakinumab + SOC or placebo + SOC and can be dosed immediately after ensuring that the patient has met all eligibility criteria. Patients in the canakinumab arm will be dosed on Day 1 with canakinumab 450 mg for body weight of 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Patients in the placebo arm will be administered with 250 mL of 5% dextrose infused IV over 2 hours.

The study will include:

  • Screening period of 0-1 day
  • Study period from initial dose on Day 1 to Day 29 or hospital discharge
  • Follow-up to Day 127 The primary objective is to demonstrate the benefit of canakinumab + SOC in increasing the chance of survival without ever requiring invasive mechanical ventilation among patients with COVID-19-induced pneumonia and CRS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : October 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: Canakinumab
Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Drug: Canakinumab
Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Other Name: ACZ885

Placebo Comparator: Placebo
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Drug: Placebo
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.




Primary Outcome Measures :
  1. Number of patients with clinical response [ Time Frame: Day 3 to Day 29 ]

    Clinical response is defined as survival without ever requiring invasive mechanical ventilation from Day 3 to Day 29 (both inclusive). A patient will be defined as a non-responder if the worst clinical status at any time from Day 3 to Day 29 is score 6, 7 or 8 on a 9-point ordinal scale ranging from 0 up to 8.

    Scores 6, 7 and 8 in the 9-point ordinal scale are defined as follows: Hospitalized patients with severe disease have score 6 if they need intubation and mechanical ventilation and score 7 if they need ventilation + additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation). Patients who die have score 8.



Secondary Outcome Measures :
  1. COVID-19-related death rate during the 4-week period after study treatment [ Time Frame: 4 weeks ]
    COVID-19-related death during the 4-week period after study treatment.

  2. Ratio to baseline in the C-reactive protein (CRP) [ Time Frame: Baseline, Day 29 ]
    Clinical chemistry measurement in a blood sample.

  3. Ratio to baseline in the serum ferritin [ Time Frame: Baseline, Day 29 ]
    Clinical chemistry measurement in a blood sample.

  4. Ratio to baseline in the D-dimer [ Time Frame: Baseline, Day 29 ]
    Clinical chemistry measurement in a blood sample.

  5. Number of participants with Adverse Event (AE), serious adverse events (SAE), clinically significant changes in laboratory measures, and vital signs [ Time Frame: 127 days ]
    Safety will be monitored from the canakinumab or placebo dose (Day 1) up to 126 days post-dose (Day 127).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key inclusion Criteria:

  • Adults (≥ 18 years old)
  • Body weight ≥40 kg
  • Informed consent must be obtained prior to participation in this study.
  • Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology
  • Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with pulmonary infiltrates
  • SpO2 ≤ 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
  • C-reactive protein ≥20 mg/L or ferritin level ≥600 µg/L

Key exclusion Criteria:

  • History of hypersensitivity to canakinumab or to biologic drugs
  • Intubated and on mechanical ventilation (invasive) at time of randomization
  • Treatment with immunomodulators or immunosuppressant drugs, including but not limited to tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives or 30 days (whichever is longer) prior to randomization with the exception of anakinra which is excluded within 5 half-lives only. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis and corticosteroids (any route of administration) are permitted.
  • Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362813


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
San Francisco, California, United States, 94110
United States, Illinois
Novartis Investigative Site Recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02118
United States, New York
Novartis Investigative Site Recruiting
Brooklyn, New York, United States, 11219
United States, North Carolina
Novartis Investigative Site Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Novartis Investigative Site Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Novartis Investigative Site Recruiting
Richmond, Virginia, United States, 23298
Germany
Novartis Investigative Site Recruiting
Lubeck, Germany, 23538
Novartis Investigative Site Recruiting
Mainz, Germany, 55131
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
San Sebastian de los Reyes, Madrid, Spain, 28702
Novartis Investigative Site Recruiting
Madrid, Spain, 28034
Novartis Investigative Site Recruiting
Madrid, Spain, 28040
Novartis Investigative Site Recruiting
Madrid, Spain, 28041
United Kingdom
Novartis Investigative Site Recruiting
Barnet, United Kingdom, EN5 3DJ
Novartis Investigative Site Recruiting
Leeds, United Kingdom, LS9 7TF
Novartis Investigative Site Recruiting
London, United Kingdom, NW3 2QG
Novartis Investigative Site Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04362813    
Other Study ID Numbers: CACZ885D2310
2020-001370-30 ( EudraCT Number )
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COVID-19
cytokine release syndrome
SARS-CoV-2
canakinumab
pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections