ArticleInfectious diseases and therapy2021
Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study).
Article in Infectious diseases and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Interleukin-6 blocking agents for treating COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023Pooled it
- Effect of tocilizumab, sarilumab, and baricitinib on mortality among patients hospitalized for COVID-19 treated with corticosteroids: a systematic review and meta-analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023Pooled it
- Clinical efficacy and safety of interleukin-6 receptor antagonists (tocilizumab and sarilumab) in patients with COVID-19: a systematic review and meta-analysis.Emerging microbes & infections · 2022Pooled it
- Investigating the impact of Tocilizumab, Sarilumab, and Anakinra on clinical outcomes in COVID-19: A systematic review andInternational journal of cardiology. Heart & vasculature · 2024Review
- Sarilumab plus standard of careEClinicalMedicine · 2023Article
- Should We Interfere with the Interleukin-6 Receptor During COVID-19: What Do We Know So Far?Drugs · 2023Review
- [Should we interfere with the interleukin-6 receptor during COVID-19: What do we know?]Revue des maladies respiratoires · 2023Review
- Immune-Based Therapy for Hospitalized Patients With COVID-19 and Risk of Secondary Infections: A Systematic Review and Meta-analysis.Open forum infectious diseases · 2023Article
- Effects of Metformin on COVID-19 Patients with Type 2 Diabetes: A Retrospective Study.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023Article
- Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review.BMJ medicine · 2023Article
- Innate immunity, cytokine storm, and inflammatory cell death in COVID-19.Journal of translational medicine · 2022Review
- IL-6 signalling biomarkers in hospitalised patients with moderate to severe SARS-CoV-2 infection in a single centre study in Sweden.Cytokine · 2022Article
- Care for adults with COVID-19: living guidelines from the National COVID-19 Clinical Evidence Taskforce.The Medical journal of Australia · 2022Article
- Inflammasomes and IL-1 family cytokines in SARS-CoV-2 infection: from prognostic marker to therapeutic agent.Cytokine · 2022Review
- Innate immunity: the first line of defense against SARS-CoV-2.Nature immunology · 2022Review
- Pharmaco-immunomodulatory interventions for averting cytokine storm-linked disease severity in SARS-CoV-2 infection.Inflammopharmacology · 2022Review
Corrections and comments
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Authors and funding
23 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS).
methodsWe randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15.
resultsA total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48-2.20). No relevant safety issues were identified.
conclusionsIn hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.