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

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.

Year of Publication: 2020
Published: Bethesda (Maryland), ClinicalTrials.gov, June 4, 2020
Language: English
Full text access: Full text access (free access)
Links: Full Text (clinicaltrials.gov)
Keywords: Clinical Study Status: Recruiting
Clinical Study
Clinical Trial, Phase III
Covid-19
Forschungsbericht
Klinische Studie
Pneumonia > MeSH
Notes: Source: ClinicalTrials.gov (no modifications made)
ClinicalTrials.gov processed this data on June 05, 2020
Last update posted on ClinicalTrials.gov: June 4, 2020
Last updated: 2020-06-08
NCT ID:
    NCT04362813

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