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

Conditions

• Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Canakinumab — DRUG
  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.
• Placebo — DRUG
  250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.

Study Details

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).

Key Dates

Start date

Apr 30, 2020

Status verified

Jan 2022

Primary completion

Sep 16, 2020

Completion

Dec 22, 2020

Study Design

Enrollment

454 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis [ Time Frame: Day 3 to Day 29 ]

Locations (15)

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