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

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).

Timeline

Start

2020-04-30

Primary completion

2020-09-16

Completion

2020-12-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Canakinumab vs Placebo; p = 0.2874; Odds Ratio (OR) 1.39 (95% CI 0.76 to 2.54); Regression, Logistic NCT04362813 ↗

paper treatment with canakinumab, compared with placebo, did not significantly increase the likelihood of survival without IMV at day 29. PMID 34283183 ↗

release “The Phase III trial investigating canakinumab plus standard of care (SoC) did not meet its primary endpoint” novartis.com ↗

Publications

• Sedhai YR, Sears M, Vecchie A, Bonaventura A, Greer J, Spence K, Tackett H, Turner J, Pak M, Patel N, Black M, Wohlford G, Clary RE, Duke C, Hardin M, Kemp H, Priday A, Sims EK Jr, Mihalick V, Ho AC, Ibe I, Harmon M, Markley R, Van Tassell B, Abbate A. Clinical trial enrollment at a rural satellite hospital during COVID-19 pandemic. J Clin Transl Sci. 2021 Apr 8;5(1):e136. doi: 10.1017/cts.2021.777. eCollection 2021.
• Caricchio R, Abbate A, Gordeev I, Meng J, Hsue PY, Neogi T, Arduino R, Fomina D, Bogdanov R, Stepanenko T, Ruiz-Seco P, Gonzalez-Garcia A, Chen Y, Li Y, Whelan S, Noviello S; CAN-COVID Investigators. Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Jul 20;326(3):230-239. doi: 10.1001/jama.2021.9508.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canakinumab	Monoclonal antibody	450 mg	Intravenous
Subject	Canakinumab	Monoclonal antibody	600 mg	Intravenous
Subject	Canakinumab	Monoclonal antibody	750 mg	Intravenous

Indications