The efficacy and safety of levilimab in severely ill COVID-19 patients not requiring mechanical ventilation: results of a multicenter randomized double-blind placebo-controlled phase III CORONA clinical study

Objective and design The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19. Subjects The study included 217 patients. The eligible were men and non-pregnant...

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Published in:	Inflammation research Vol. 70; no. 10-12; pp. 1233 - 1246
Main Authors:	Lomakin, Nikita V., Bakirov, Bulat A., Protsenko, Denis N., Mazurov, Vadim I., Musaev, Gaziyavdibir H., Moiseeva, Olga M., Pasechnik, Elena S., Popov, Vladimir V., Smolyarchuk, Elena A., Gordeev, Ivan G., Gilyarov, Mikhail Yu, Fomina, Darya S., Seleznev, Anton I., Linkova, Yulia N., Dokukina, Ekaterina A., Eremeeva, Anna V., Pukhtinskaia, Polina S., Morozova, Maria A., Zinkina-Orikhan, Arina V., Lutckii, Anton A.
Format:	Journal Article
Language:	English
Published:	Cham Springer International Publishing 01-12-2021 Springer Nature B.V
Subjects:	Adolescent Adult Aged Aged, 80 and over Allergology Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - therapeutic use Biomedical and Life Sciences Biomedicine Clinical trials Coronaviruses COVID-19 COVID-19 Drug Treatment Dermatology Double-Blind Method Double-blind studies Endpoint Determination Female Humans Immunology Injections, Subcutaneous Interleukin 6 Interleukin 6 receptors Male Mechanical ventilation Middle Aged Missing data NCT NCT04397562 Neurology Original Original Research Article Oxygen Inhalation Therapy Patients Pharmacology/Toxicology Placebos Pneumonia Receptors, Interleukin-6 - antagonists & inhibitors Respiration, Artificial Rheumatology Safety Severe acute respiratory syndrome coronavirus 2 Side effects Therapy Treatment Outcome Ventilation Viral diseases Young Adult COVID-19 Levilimab 7-category ordinal scale IL-6R inhibitor
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Summary:	Objective and design The aim of this double-blind, placebo-controlled, phase III CORONA clinical trial was to evaluate the efficacy and safety of IL-6 receptor inhibitor levilimab (LVL) in subjects with severe COVID-19. Subjects The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia. Treatment 206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 mg or placebo, both in combination with standard of care (SOC). 204 patients received allocated therapy. After the LVL/placebo administration in case of deterioration of symptoms, the investigator could perform a single open-label LVL 324 mg administration as the rescue therapy. Methods The primary efficacy endpoint was the proportion of patients with sustained clinical improvement on the 7-category ordinal scale on Day 14. All efficacy data obtained after rescue therapy administration were considered missing. For primary efficacy analysis, all subjects with missing data were considered non-responders. Results 63.1% and 42.7% of patients in the LVL and in the placebo groups, respectively, achieved sustained clinical improvement on Day 14 ( P = .0017). The frequency of adverse drug reactions was comparable between the groups. Conclusion In patients with radiologically confirmed SARS-CoV-2 pneumonia, requiring or not oxygen therapy (but not ventilation) with no signs of other active infection administration of LVL + SOC results in an increase of sustained clinical improvement rate. Trail registration The trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).
Bibliography:	Responsible Editor: Anatoliy Kubyshkin.
ISSN:	1023-3830 1420-908X
DOI:	10.1007/s00011-021-01507-5