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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.
- Source :
-
Inflammation research : official journal of the European Histamine Research Society ... [et al.] [Inflamm Res] 2021 Dec; Vol. 70 (10-12), pp. 1233-1246. Date of Electronic Publication: 2021 Sep 29. - Publication Year :
- 2021
-
Abstract
- 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.<br />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.<br />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.<br />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.<br />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.<br />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.<br />Trail Registration: The trial is registered at the US National Institutes of Health (ClinicalTrials.gov; NCT04397562).<br /> (© 2021. The Author(s).)
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized adverse effects
Double-Blind Method
Endpoint Determination
Female
Humans
Injections, Subcutaneous
Male
Middle Aged
Oxygen Inhalation Therapy
Respiration, Artificial
Treatment Outcome
Young Adult
Antibodies, Monoclonal, Humanized therapeutic use
Receptors, Interleukin-6 antagonists & inhibitors
COVID-19 Drug Treatment
Subjects
Details
- Language :
- English
- ISSN :
- 1420-908X
- Volume :
- 70
- Issue :
- 10-12
- Database :
- MEDLINE
- Journal :
- Inflammation research : official journal of the European Histamine Research Society ... [et al.]
- Publication Type :
- Academic Journal
- Accession number :
- 34586459
- Full Text :
- https://doi.org/10.1007/s00011-021-01507-5