Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia : 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)
This was 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 enrolled patients to canakinumab or placebo, in addition to standard of care (SOC) per local practice, which may have included anti-viral treatment, corticosteroids and/or supportive care.Patients who met the inclusion/exclusion criteria were randomized in a 1:1 ratio to either canakinumab + SOC or placebo + SOC and were dosed immediately after ensuring that the patient met all eligibility criteria. Patients in the canakinumab arm were 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 were administered with 250 mL of 5% dextrose infused IV over 2 hours.The study included:Screening period of 0-1 dayStudy period from initial dose on Day 1 to Day 29 or hospital dischargeFollow-up to Day 127 The primary objective was 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..
Medienart: |
Klinische Studie |
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Erscheinungsjahr: |
2022 |
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Erschienen: |
2022 |
Enthalten in: |
ClinicalTrials.gov - (2022) vom: 24. Jan. Zur Gesamtaufnahme - year:2022 |
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Sprache: |
Englisch |
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Links: |
Volltext [kostenfrei] |
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Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: April 27, 2020, Last downloaded: ClinicalTrials.gov processed this data on January 31, 2022, Last updated: February 02, 2022 |
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Study ID: |
NCT04362813 |
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Veröffentlichungen zur Studie: |
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fisyears: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
CTG003372200 |
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520 | |a This was 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 enrolled patients to canakinumab or placebo, in addition to standard of care (SOC) per local practice, which may have included anti-viral treatment, corticosteroids and/or supportive care.Patients who met the inclusion/exclusion criteria were randomized in a 1:1 ratio to either canakinumab + SOC or placebo + SOC and were dosed immediately after ensuring that the patient met all eligibility criteria. Patients in the canakinumab arm were 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 were administered with 250 mL of 5% dextrose infused IV over 2 hours.The study included:Screening period of 0-1 dayStudy period from initial dose on Day 1 to Day 29 or hospital dischargeFollow-up to Day 127 The primary objective was 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. | ||
650 | 2 | |a COVID-19 | |
650 | 2 | |a Pneumonia | |
650 | 2 | |a Syndrome | |
650 | 2 | |a Cytokine Release Syndrome | |
650 | 4 | |a Medical Condition: Cytokine Release Syndrome (CRS) in Patients With COVID-19-induced Pneumonia | |
650 | 4 | |a Study Type: Interventional | |
650 | 4 | |a Recruitment Status: Completed | |
650 | 4 | |a Phase: Phase 3 | |
650 | 4 | |a 610 | |
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