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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

Lomakin et al., Inflammation Research, doi:10.1007/s00011-021-01507-5, CORONA, NCT04397562
Sep 2021  
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Mortality 0% Improvement Relative Risk ICU admission 70% Sustained clinical improve.. 65% Levilimab  CORONA  LATE TREATMENT  DB RCT Is late treatment with levilimab beneficial for COVID-19? Double-blind RCT 206 patients in Russia (April - August 2020) Greater improvement with levilimab (p=0.0000079) c19early.org Lomakin et al., Inflammation Research, Sep 2021 Favorslevilimab Favorscontrol 0 0.5 1 1.5 2+
RCT 206 severe COVID-19 patients not requiring mechanical ventilation, showing higher sustained clinical improvement and lower ICU admission with levilimab. There was no difference in mortality.
risk of death, no change, RR 1.00, p = 1.00, treatment 4 of 103 (3.9%), control 4 of 103 (3.9%).
risk of ICU admission, 70.0% lower, RR 0.30, p = 0.08, treatment 3 of 103 (2.9%), control 10 of 103 (9.7%), NNT 15.
sustained clinical improvement, 65.2% lower, RR 0.35, p < 0.001, treatment 16 of 103 (15.5%), control 46 of 103 (44.7%), NNT 3.4, day 30.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Lomakin et al., 29 Sep 2021, Double Blind Randomized Controlled Trial, placebo-controlled, Russia, peer-reviewed, mean age 58.5, 20 authors, study period April 2020 - August 2020, trial NCT04397562 (history) (CORONA). Contact: puhtinskaya@biocad.ru.
This PaperLevilimabAll
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
Nikita V Lomakin, Bulat A Bakirov, Denis N Protsenko, Vadim I Mazurov, Gaziyavdibir H Musaev, Olga M Moiseeva, Elena S Pasechnik, Vladimir V Popov, Elena A Smolyarchuk, Ivan G Gordeev, Mikhail Yu Gilyarov, Darya S Fomina, Anton I Seleznev, Yulia N Linkova, Ekaterina A Dokukina, Anna V Eremeeva, Polina S Pukhtinskaia, Maria A Morozova, Arina V Zinkina-Orikhan, Anton A Lutckii
Inflammation Research, doi:10.1007/s00011-021-01507-5
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.
Authors and Affiliations Nikita V. Lomakin
References
Cao, Wang, Wen, Liu, Wang et al., A trial of lopinavir-ritonavir in adults hospitalized with severe Covid-19, N Engl J Med
Capra, Rossi, Mattioli, Romanelli, Scarpazza et al., Impact of low dose tocilizumab on mortality rate in patients with COVID-19 related pneumonia, Eur J Intern Med
Cevik, Bamford, Ho, COVID-19 pandemic-a focused review for clinicians, Clin Microbiol Infect
Coomes, Haghbayan, Interleukin-6 in Covid-19: a systematic review and meta-analysis, Rev Med Virol
Furlow, COVACTA trial raises questions about tocilizumab's benefit in COVID-19, Lancet Rheumatol
Group, Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial, Lancet
Hermine, Tharaux, Resche-Rigon, Porcher, Ravaud, Effect of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial, JAMA Intern Med
Hojyo, Uchida, Tanaka, Hasebe, Tanaka et al., How COVID-19 induces cytokine storm with high mortality, Inflamm Regen
Investigators, Gordon, Mouncey, Al-Beidh, Rowan et al., Interleukin-6 receptor antagonists in critically Ill patients with Covid-19, N Engl J Med
Khlyabova, Eremeeva, Lutckii, Dokukina, Chernyaeva et al., SAT0040 Safety, tolerability, pharmacokinetics and pharmacodynamics of bcd-089, novel monoclonal anti-il-6 receptor antibody: results from the first-in-human single dose escalation study in healthy volunteers, Ann Rheum Dis
Laing, Lorenc, Molino, Barrio, Das et al., A dynamic COVID-19 immune signature includes associations with poor prognosis, Nat Med
Martinez-Sanz, Ron, Herrera, Perez-Molina, Moreno, Effects of tocilizumab on mortality in hospitalized patients with COVID-19: a multicentre cohort study, Clin Microbiol Infect
Mason, Pathogenesis of COVID-19 from a cell biology perspective, Eur Respir J, doi:10.1183/13993003.00607-2020
Mazurov, Zotkin, Ilivanova, Kropotina, Plaksina et al., FRI0114 efficacy of levilimab, novel monoclonal anti-il-6 receptor antibody, in combination with methotrexate in patients with rheumatoid arthritis: 1 year results of phase 2 AURORA study, Ann Rheum Dis
Mccaw, Tian, Vassy, Ritchie, Lee et al., How to quantify and interpret treatment effects in comparative clinical studies of COVID-19, Ann Intern Med
Rosas, Brau, Waters, Go, Hunter et al., Tocilizumab in hospitalized patients with severe Covid-19 pneumonia, N Engl J Med
Salama, Han, Yau, Reiss, Kramer et al., Tocilizumab in patients hospitalized with Covid-19 pneumonia, N Engl J Med
Somers, Eschenauer, Troost, Golob, Gandhi et al., Tocilizumab for treatment of mechanically ventilated patients with COVID-19, Clin Infect Dis
Stone, Frigault, Serling-Boyd, Fernandes, Harvey et al., Efficacy of tocilizumab in patients hospitalized with Covid-19, N Engl J Med
Wang, Zhang, Du, Du, Zhao, Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial, Lancet
Zeraatkar, Cusano, Martinez, Qasim, Mangala et al., Tocilizumab and sarilumab alone or in combination with corticosteroids for COVID-19: a systematic review and network meta-analysis, doi:10.1101/2021.07.05.21259867
Zhou, Price, Overview on the use of IL-6 agents in the treatment of patients with cytokine release syndrome (CRS) and pneumonitis related to COVID-19 disease, Expert Opin Investig Drugs
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Clin Infect Dis. 2021;73(2):e445–54.', 'journal-title': 'Clin Infect Dis'}, { 'issue': '2', 'key': '1507_CR20', 'doi-asserted-by': 'publisher', 'first-page': '238', 'DOI': '10.1016/j.cmi.2020.09.021', 'volume': '27', 'author': 'J Martinez-Sanz', 'year': '2021', 'unstructured': 'Martinez-Sanz J, Muriel A, Ron R, Herrera S, Perez-Molina JA, Moreno S, ' 'et al. Effects of tocilizumab on mortality in hospitalized patients with ' 'COVID-19: a multicentre cohort study. Clin Microbiol Infect. ' '2021;27(2):238–43.', 'journal-title': 'Clin Microbiol Infect'}, { 'issue': '10285', 'key': '1507_CR21', 'doi-asserted-by': 'publisher', 'first-page': '1637', 'DOI': '10.1016/S0140-6736(21)00676-0', 'volume': '397', 'author': 'Group RC', 'year': '2021', 'unstructured': 'Group RC. Tocilizumab in patients admitted to hospital with COVID-19 ' '(RECOVERY): a randomised, controlled, open-label, platform trial. ' 'Lancet. 2021;397(10285):1637–45.', 'journal-title': 'Lancet'}, { 'key': '1507_CR22', 'doi-asserted-by': 'publisher', 'unstructured': 'Zeraatkar D, Cusano E, Martinez JPD, Qasim A, Mangala SO, Kum E, et al. ' '(2021) Tocilizumab and sarilumab alone or in combination with ' 'corticosteroids for COVID-19: a systematic review and network ' 'meta-analysis. medRxiv. 2021.07.05.21259867. ' 'https://doi.org/10.1101/2021.07.05.21259867', 'DOI': '10.1101/2021.07.05.21259867'}], 'container-title': 'Inflammation Research', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s00011-021-01507-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s00011-021-01507-5/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s00011-021-01507-5.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 11, 7]], 'date-time': '2021-11-07T14:04:07Z', 'timestamp': 1636293847000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s00011-021-01507-5'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 9, 29]]}, 'references-count': 22, 'journal-issue': {'issue': '10-12', 'published-print': {'date-parts': [[2021, 12]]}}, 'alternative-id': ['1507'], 'URL': 'http://dx.doi.org/10.1007/s00011-021-01507-5', 'relation': {}, 'ISSN': ['1023-3830', '1420-908X'], 'subject': ['Pharmacology', 'Immunology'], 'container-title-short': 'Inflamm. Res.', 'published': {'date-parts': [[2021, 9, 29]]}, 'assertion': [ { 'value': '11 July 2021', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '14 September 2021', 'order': 2, 'name': 'revised', 'label': 'Revised', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '16 September 2021', 'order': 3, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '29 September 2021', 'order': 4, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'The research leading to these results received funding from BIOCAD under Grant ' 'Agreement No BCD-089-4/CORONA. Authors Nikita V. Lomakin, Bulat A. Bakirov, ' 'Denis N. Protsenko, Vadim I. Mazurov, Gaziyavdibir H. Musaev, Olga M. Moiseeva, ' 'Elena S. Pasechnik, Vladimir V. Popov, Elena A. Smolyarchuk, Ivan G. Gordeev, ' 'Darya S. Fomina have no conflicts of interest to declare that are relevant to ' 'the content of this article. Author Mikhail Yu. Gilyarov received a speaking ' 'fee from Boehringer Ingelheim, Bayer, Pfizer и Servier. Authors Anton I. ' 'Seleznev, Yulia N. Linkova, Ekaterina A. Dokukina, Polina S. Pukhtinskaia, Anna ' 'V. Eremeeva, Maria A. Morozova, Arina V. Zinkina-Orikhan and Anton A. Lutckii, ' 'are JSC BIOCAD employees.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Conflict of interest'}}, { 'value': 'This study was performed in line with the principles of the Declaration of ' 'Helsinki of 1964, and its later amendments and was approved by the Central ' 'Regulatory Authorities of the Russian Federation (Authorization by the Ministry ' 'of Healthcare of the Russian Federation No. 176 of April 22, 2020; Extract from ' 'minutes of Ethics Council of Ministry of Health of The Russian Federation ' 'No.216, dated 21th of April, 2020) and Ethical Review Boards of each of the ' 'participating sites.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethical approval'}}, { 'value': 'Informed consent was obtained from all individual participants included in the ' 'study.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent to participate'}}, { 'value': 'There is no identifiable information in the manuscript. Patients signed ' 'informed consent which included information about publishing the analyzed data.', 'order': 5, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent to publish'}}]}
Late treatment
is less effective
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