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Monoclonal Antibodies

Canakinumab for Cytokine Release Syndrome (CAN-COVID Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over time and up to day 29: baseline, day 2, day 3, day 5, day 7, day 9, day 11, day 13, day 15, day 17, day 19, day 21, day 23, day 25, day 27 and day 29.
Awards & highlights

CAN-COVID Trial Summary

This was 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 patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

Eligible Conditions
  • Cytokine Release Syndrome

CAN-COVID Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over time and up to day 29: baseline, day 2, day 3, day 5, day 7, day 9, day 11, day 13, day 15, day 17, day 19, day 21, day 23, day 25, day 27 and day 29.
This trial's timeline: 3 weeks for screening, Varies for treatment, and over time and up to day 29: baseline, day 2, day 3, day 5, day 7, day 9, day 11, day 13, day 15, day 17, day 19, day 21, day 23, day 25, day 27 and day 29. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis
Secondary outcome measures
COVID-19-related Death After Study Treatment
Geometric Mean Ratio to Baseline in Ferritin
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
+2 more

Side effects data

From 2017 Phase 3 trial • 203 Patients • NCT02059291
33%
Familial mediterranean fever
26%
Abdominal pain
26%
Headache
23%
Back pain
21%
Diarrhoea
21%
Pyrexia
20%
Upper respiratory tract infection
20%
Arthralgia
18%
Injection site reaction
18%
Influenza
15%
Urinary tract infection
15%
Gastroenteritis
15%
Pain in extremity
13%
Viral upper respiratory tract infection
13%
Pharyngitis
13%
Tonsillitis
13%
Oropharyngeal pain
11%
Non-cardiac chest pain
11%
Myalgia
10%
Abdominal pain upper
10%
Nausea
10%
Vomiting
10%
Influenza like illness
10%
Viral infection
10%
Cough
8%
Lymphadenopathy
8%
Constipation
8%
Erythema
7%
Dizziness
7%
Joint swelling
7%
Musculoskeletal pain
5%
Anaemia
5%
Nasopharyngitis
5%
Neutropenia
5%
Rhinitis
5%
Oral herpes
5%
Pneumonia
5%
Rash
3%
Tachycardia
3%
Dental caries
3%
Toothache
3%
Asthenia
3%
Conjunctivitis
3%
Lower respiratory tract infection
3%
Drug eruption
3%
Umbilical hernia
3%
Aphthous ulcer
3%
Gastritis
3%
Ear infection
3%
Sinusitis
3%
Ligament sprain
3%
Dehydration
3%
Epistaxis
3%
Urticaria
3%
Cellulitis
3%
Dyspepsia
3%
Eczema
2%
Bile duct stone
2%
Cardiac failure congestive
2%
Hepatic cirrhosis
2%
Acute sinusitis
2%
Infectious colitis
2%
Pelvic abscess
2%
Obesity
2%
Schizophrenia
2%
Haemorrhoids
2%
Mouth ulceration
2%
Skin abrasion
2%
Blood creatine phosphokinase increased
2%
Neck pain
2%
Pain of skin
2%
Pyoderma gangrenosum
2%
Thyroiditis
2%
Ascites
2%
Ileal ulcer
2%
Granulomatous liver disease
2%
Peritonitis
2%
Hypokalaemia
2%
Pleurisy
2%
Scleritis
2%
Stomatitis
2%
Fatigue
2%
Bronchitis
2%
Pharyngotonsillitis
2%
Respiratory tract infection
2%
Sialoadenitis
2%
Arthritis
2%
Spinal pain
2%
Pyogenic granuloma
2%
Somnolence
2%
Dermatitis allergic
2%
Skin ulcer
2%
Bursitis
2%
Vocal cord polyp
2%
Ear pain
2%
Keloid scar
2%
Malaise
2%
Rash pruritic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events
Randomized ACZ and Placebo crFMF Patients - ACZ Events
Any ACZ crFMF Patients - ACZ Events
Randomized ACZ and Placebo TRAPS Patients - ACZ Events
Non-randomized Open Label crFMF, HIDS/MKD Patients
Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo crFMF Pts - No Medication Events
Non-randomized Open Label TRAPS Patients
Any ACZ crFMF Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Patients - Placebo Events
Randomized ACZ and Placebo TRAPS Pts - No Medication Events
Any ACZ HIDS/MKD Patients - No Medication Events
Any ACZ HIDS/MKD Patients - ACZ Events
Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events
Any ACZ TRAPS Patients - Placebo Events
Any ACZ TRAPS Patients - ACZ Events
Randomized ACZ and Placebo crFMF Patients - Placebo Events
Any ACZ TRAPS Patients - no Medication Events
Any ACZ HIDS/MKD Patients - Placebo Events
Any ACZ crFMF Patients - No Medication Events

CAN-COVID Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CanakinumabExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,872 Previous Clinical Trials
4,199,376 Total Patients Enrolled
2 Trials studying Cytokine Release Syndrome
432 Patients Enrolled for Cytokine Release Syndrome
~89 spots leftby Jun 2025
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