There is one clinical trial.
This is 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 adult patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).
Description: Clinical response is defined as survival without ever requiring invasive mechanical ventilation from Day 3 to Day 29 (both inclusive). A patient will be defined as a non-responder if the worst clinical status at any time from Day 3 to Day 29 is score 6, 7 or 8 on a 9-point ordinal scale ranging from 0 up to 8. Scores 6, 7 and 8 in the 9-point ordinal scale are defined as follows: Hospitalized patients with severe disease have score 6 if they need intubation and mechanical ventilation and score 7 if they need ventilation + additional organ support (pressors, renal replacement therapy, extracorporeal membrane oxygenation). Patients who die have score 8.Measure: Number of patients with clinical response Time: Day 3 to Day 29
Description: COVID-19-related death during the 4-week period after study treatment.Measure: COVID-19-related death rate during the 4-week period after study treatment Time: 4 weeks
Description: Clinical chemistry measurement in a blood sample.Measure: Ratio to baseline in the C-reactive protein (CRP) Time: Baseline, Day 29
Description: Clinical chemistry measurement in a blood sample.Measure: Ratio to baseline in the serum ferritin Time: Baseline, Day 29
Description: Clinical chemistry measurement in a blood sample.Measure: Ratio to baseline in the D-dimer Time: Baseline, Day 29
Description: Safety will be monitored from the canakinumab or placebo dose (Day 1) up to 126 days post-dose (Day 127).Measure: Number of participants with Adverse Event (AE), serious adverse events (SAE), clinically significant changes in laboratory measures, and vital signs Time: 127 days