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c19early.org
Sarilumab for COVID-19
11 studies with >2,000 patients
Serious outcome risk
Sarilumab
Control
No significant improvements are seen in meta-analysis to date.
COVID-19 Sarilumab studies · October 2026
Covid Analysis Sarilumab for COVID-19: real-time meta-analysis of 11 studies (Version 10)
Meta-analysis using the most serious outcome reported shows 0% [-17‑21%] higher risk, without reaching statistical significance. Currently all studies are RCTs. All data and sources to reproduce this analysis are in the appendix.
Mar 6
2025
 Htet et al., British Journal of Clinical Pharmacology, doi:10.1002/bcp.70025 Adverse events associated with monoclonal antibodies used for treatment of COVID‐19: A systematic review and meta‐analysis
Systematic review and meta-analysis of 16 RCTs with 19,797 COVID-19 patients, showing a statistically significant increased risk of hepatotoxicity and neutropenia associated with monoclonal antibody (mAb) treatments compared to standard o..
Mar 31
2023
 Mastrorosa et al., eClinicalMedicine, doi:10.1016/j.eclinm.2023.101895 Sarilumab plus standard of care vs standard of care for the treatment of severe COVID-19: a phase 3, randomized, open-labeled, multi-center study (ESCAPE study)
30% higher mortality (p=0.67), 7% greater improvement (p=0.69), and 8% worse viral clearance (p=1). RCT with 176 severe COVID-19 patients showing no significant difference in time to clinical improvement or 30 day mortality with sarilumab treatment.
Feb 26
2022
 Sivapalasingam et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac153 Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
7% higher mortality (p=0.89) and 4% worse improvement (p=0.91). Phase 2 and phase 3 RCTs with 1,365 hospitalized COVID-19 patients showing no significant improvement with sarilumab vs placebo. Post-hoc analysis suggests a potential mortality benefit with sarilumab in mechanically ventilated patients r..
Feb 26
2022
 Sivapalasingam et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac153 Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial
8% higher mortality (p=0.59) and 6% worse improvement (p=0.47). Phase 2 and phase 3 RCTs with 1,365 hospitalized COVID-19 patients showing no significant improvement with sarilumab vs placebo. Post-hoc analysis suggests a potential mortality benefit with sarilumab in mechanically ventilated patients r..
Feb 25
2022
 Branch-Elliman et al., PLOS ONE, doi:10.1371/journal.pone.0263591 Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial
350% higher mortality (p=0.05), 650% higher combined mortality/intubation (p=0.03), and 500% higher ventilation (p=0.16). RCT 50 hospitalized moderate-to-severe COVID-19 patients showing higher mortality with subcutaneous sarilumab compared to standard of care. The study was stopped early due to a high probability of futility and potential harm.
Feb 23
2022
 García-Vicuña et al., Frontiers in Medicine, doi:10.3389/fmed.2022.819621 Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial
300% higher mortality (p=0.54), 450% higher ventilation (p=0.53), and 33% worse 7-point scale results (p=0.36). RCT 30 hospitalized moderate-to-severe COVID-19 patients showing no significant difference in 30-day mortality, clinical improvement at day 7, or time to discharge with sarilumab compared to standard care.
Feb 15
2022
 Merchante et al., Antimicrobial Agents and Chemotherapy, doi:10.1128/AAC.02107-21 Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial
35% higher mortality (p=0.71), 22% higher ventilation (p=0.7), and 36% lower progression (p=0.23). RCT 115 hospitalized COVID-19 pneumonia patients in Spain showing a trend towards reduced progression to severe respiratory failure requiring high-flow oxygen, non-invasive ventilation, or mechanical ventilation, and reduced mortality, wi..
Feb 3
2022
 Hermine et al., European Respiratory Journal, doi:10.1183/13993003.02523-2021 Effect of interleukin-6 receptor antagonists in critically ill adult patients with COVID-19 pneumonia: two randomised controlled trials of the CORIMUNO-19 Collaborative Group
26% lower mortality (p=0.44). Two open-label RCTs of 97 and 91 critically ill COVID-19 patients in France showing no significant differences with tocilizumab or sarilumab.
Jan 31
2022
 Mariette et al., The Lancet Rheumatology, doi:10.1016/S2665-9913(21)00315-5 Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial
30% lower mortality (p=0.4), 1% worse recovery (p=1), and 10% higher progression (p=0.7). RCT 148 hospitalized patients with moderate-to-severe COVID-19 pneumonia in France showing no significant differences with sarilumab treatment.
Nov 30
2021
 Abraham et al., Current Medicine Research and Practice, doi:10.4103/cmrp.cmrp_71_21 Tolerability of Sarilumab – An anti-interleukin-6 receptor monoclonal antibody is controversial for the management of COVID-19
Review of sarilumab, an anti-interleukin-6 receptor monoclonal antibody, for the management of COVID-19. Authors report that sarilumab was proposed as a potential treatment to reduce mortality by abating the inflammatory cytokine storm in..
Oct 17
2021
 Sancho-López et al., Infectious Diseases and Therapy, doi:10.1007/s40121-021-00543-2 Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)
3% higher mortality (p=0.98), 30% lower ICU admission (p=0.5), and 14% worse recovery (p=0.66). RCT 201 hospitalized COVID-19 pneumonia patients under standard oxygen therapy in Spain showing no significant difference with sarilumab treatment.
May 31
2021
 Lescure et al., The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00099-0 Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial
2% lower mortality (p=0.96), 5% higher ICU admission (p=0.89), and 8% greater improvement (p=0.47). RCT 416 hospitalized severe or critical COVID-19 patients showing no significant difference with intravenous sarilumab compared to placebo for clinical improvement, survival at day 29, or other secondary outcomes.
Apr 22
2021
 Gordon et al., New England Journal of Medicine, doi:10.1056/NEJMoa2100433 Interleukin-6 Receptor Antagonists in Critically Ill Patients with Covid-19
26% lower mortality (p=0.39). RCT 803 critically ill COVID-19 patients showing improved outcomes with tocilizumab and sarilumab. There was only 48 sarilumab patients and the model used shrinks the posterior distribution for each intervention effect toward the overall ..