Dataset Information

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.

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.

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).

SUBMITTER: Lomakin NV

PROVIDER: S-EPMC8479713 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

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.

Lomakin Nikita V NV Bakirov Bulat A BA Protsenko Denis N DN Mazurov Vadim I VI Musaev Gaziyavdibir H GH Moiseeva Olga M OM Pasechnik Elena S ES Popov Vladimir V VV Popov Vladimir V VV Smolyarchuk Elena A EA Gordeev Ivan G IG Gilyarov Mikhail Yu MY Fomina Darya S DS Seleznev Anton I AI Linkova Yulia N YN Dokukina Ekaterina A EA Eremeeva Anna V AV Pukhtinskaia Polina S PS Morozova Maria A MA Zinkina-Orikhan Arina V AV Lutckii Anton A AA

Inflammation research : official journal of the European Histamine Research Society ... [et al.] 20210929 10-12

<h4>Objective and design</h4>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.<h4>Subjects</h4>The study included 217 patients. The eligible were men and non-pregnant women aged 18 years or older, hospitalized for severe COVID-19 pneumonia.<h4>Treatment</h4>206 subjects were randomized (1:1) to receive single subcutaneous administration of LVL 324 m ...[more]

PMID: 34586459

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Dataset Information

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

Subjects

Treatment

Methods

Results

Conclusion

Trail registration

Publications

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.

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