Efficacy of levilimab for prevention of hospitalizations in the outpatients with COVID-19

Nizhenko T.N.: Sechenov First Moscow State Medical University, Moscow

Sizova Zh.M.: Sechenov First Moscow State Medical University, Moscow

Drozdov V.N.: Department of Clinical Pharmacology and Propedeutics of Internal Diseases, Sechenov First Moscow State Medical University

Shikh E.V.: Department of Clinical Pharmacology and Propaedeutics of Internal Diseases, Sechenov First Moscow State Medical University, Moscow

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Summary

Aim

To evaluate the efficacy of early administration of levilimab for prevention of hospitalizations in outpatients with COVID-19.

Material and methods

120 outpatients with COVID-19 were enrolled in the prospective study. 76 patients (47 males, mean age 46.7 years) from the study group were treated with two subcutaneous injections of levelimab (162 mg) on top of the standard therapy, whereas 44 patients (21 males, mean age 46.3 years) from the control group were treated only with standard agents.

Results

Two groups were similar in demographic and clinical characteristics. Patients who received outpatient therapy with levilimab showed more rapid improvement of fever, blood oxygen saturation, the extent of lung involvement on computed tomography and laboratory paramenters of inflammation, that is, C-reactive protein and fibrinogen. In the study population, the risk of hospitalization was associated with arterial hypertension (relative risk [RR] 1.49; 95% confidence interval [CI] 0.8-2.8; p=0.123), body mass index >30 kg/m2 (1.96; 1.52-3.20; p=0.007) and the extent of lung involvement 25-50% (8.37; 2.37-29.3; p=0.0009). Among patients treated with levilimab, the hospitalization rate was significantly lower than in the control group (17.1% and 36.4%, respectively; RR 0.47; 95% CI 0.25-0.88; p=0.019). Early administration of levilimab resulted also in a lower risk of hospitalization among patients with at least one risk factor for severe COVID-19 (23.8% and 50.0%, respectively; RR 0.47, 95% CI 0.24-0.94; p=0.033).

Conclusion

Early use of levilimab in the outpatient setting may reduce the severity of COVID-19 and the risk of hospitalization.

Key words

COVID-19, levilimab, risk of hospitalization, severity , efficacy.