CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 454 enrolled
Drug / intervention
Canakinumab +1 moredrug
Likely dose
Canakinumab 450 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04362813
NCT04362813Phase 3Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Apr 27, 2020·Updated Jan 24, 2022

In Brief

A Phase 3 clinical trial evaluating Canakinumab and Placebo for Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia. Completed, enrolled 454 participants across 39 sites in 6 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia
CountriesFrance, Italy, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 27, 2020
Enrollment StartApr 30, 2020
Primary CompletionSep 16, 2020
Study CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.2 years ago

Interventions

Canakinumabdrug

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.

Placebodrug

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