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
| Autor: | Vladimir V. Popov, Yulia N. Linkova, Arina V. Zinkina-Orikhan, Bulat A. Bakirov, Olga M. Moiseeva, Maria A. Morozova, Nikita V. Lomakin, E. Dokukina, A. Eremeeva, Elena S. Pasechnik, Anton A. Lutckii, Mikhail Yu Gilyarov, Mazurov Vi, Anton I. Seleznev, Polina S. Pukhtinskaia, Gaziyavdibir H. Musaev, Elena A Smolyarchuk, Denis N. Protsenko, Dar'ya S. Fomina, Ivan G. Gordeev |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Neurology Adolescent Endpoint Determination Injections Subcutaneous medicine.medical_treatment Immunology Antibodies Monoclonal Humanized Placebo Young Adult Double-Blind Method Oxygen therapy Internal medicine medicine Humans Original Research Article Young adult Aged Aged 80 and over IL-6R inhibitor Pharmacology Mechanical ventilation business.industry Oxygen Inhalation Therapy COVID-19 Middle Aged medicine.disease Receptors Interleukin-6 Respiration Artificial Rheumatology COVID-19 Drug Treatment Clinical trial Pneumonia Treatment Outcome Levilimab Female 7-category ordinal scale business |
| Zdroj: | Inflammation Research |
| ISSN: | 1420-908X 1023-3830 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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