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CanakinumabWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)


Name (Synonyms) Correlation
drug616 Placebo Wiki 0.10

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.08

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 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 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).

NCT04362813 COVID-19 Drug: Canakinumab Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

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

Secondary Outcomes

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


Related HPO nodes (Using clinical trials)