Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022
Efficacy and Safety of Sarilumab in Hospitalized Patients With Coronavirus Disease 2019: A Randomized Clinical Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04315298 (An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Interleukin-6 blocking agents for treating COVID-19: a living systematic review.The Cochrane database of systematic reviews · 2023Pooled it
- Comparison of Preprint Postings of Randomized Clinical Trials on COVID-19 and Corresponding Published Journal Articles: A Systematic Review.JAMA network open · 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
- Effect of IL-6R blockade on plasma lipids and clinical outcomes among hospitalized patients with COVID-19 infection.Journal of lipid research · 2024Trial
- Refining therapeutic targeting of interleukin-6 by signalling mode selectivity.Nature reviews. Drug discovery · 2026Review
- Decoding lung-kidney interactions in sepsis: an integrated view of molecular mechanisms, pathophysiology, and therapeutic interventions.Frontiers in immunology · 2026Review
- Weathering the Storm: How Age and Biologics Influence the COVID-19 Cytokine Surge.Pathogens (Basel, Switzerland) · 2025Review
- A meta-analysis of the efficacy and safety of immunomodulators in the treatment of severe COVID-19.The Journal of international medical research · 2025Article
- COVID-19: A Disease Driven by Protease/Antiprotease Imbalance? A Specific Review Five Years into the Pandemic.Infection and drug resistance · 2025Review
- Effect of Anti-Interleukin-6 Agents on Psychopathology in a Sample of Patients with Post-COVID-19 Syndrome: An Observational Study.Brain sciences · 2024Article
- Efficacy and safety of interleukin-6 receptor antagonists in adult patients admitted to intensive care unit with COVID-19: A systematic review andPreventive medicine reports · 2023Review
- Machine learning links unresolving secondary pneumonia to mortality in patients with severe pneumonia, including COVID-19.The Journal of clinical investigation · 2023Article
- Pulmonary drug delivery for acute respiratory distress syndrome.Pulmonary pharmacology & therapeutics · 2023Review
- Sarilumab plus standard of careEClinicalMedicine · 2023Article
- A Clinical Insight on New Discovered Molecules and Repurposed Drugs for the Treatment of COVID-19.Vaccines · 2023Review
- Liver injury in COVID-19: Clinical features, potential mechanisms, risk factors and clinical treatments.World journal of gastroenterology · 2023Review
- [Should we interfere with the interleukin-6 receptor during COVID-19: What do we know?]Revue des maladies respiratoires · 2023Review
- Care for adults with COVID-19: living guidelines from the National COVID-19 Clinical Evidence Taskforce.The Medical journal of Australia · 2022Article
- Management of hyperinflammation in COVID-19 patients.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2022Review
- Crosstalk between gut microbiota and COVID-19 impacts pancreatic cancer progression.World journal of gastrointestinal oncology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
40 authors at 11 institutions in 1 country.
Funding
Abstract
backgroundOpen-label platform trials and a prospective meta-analysis suggest efficacy of anti-interleukin (IL)-6R therapies in hospitalized patients with coronavirus disease 2019 (COVID-19) receiving corticosteroids. This study evaluated the efficacy and safety of sarilumab, an anti-IL-6R monoclonal antibody, in the treatment of hospitalized patients with COVID-19.
methodsIn this adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial, adults hospitalized with COVID-19 received intravenous sarilumab 400 mg or placebo. The phase 3 primary analysis population included patients with critical COVID-19 receiving mechanical ventilation (MV). The primary outcome was proportion of patients with ≥1-point improvement in clinical status from baseline to day 22.
resultsThere were 457 and 1365 patients randomized and treated in phases 2 and 3, respectively. In phase 3, patients with critical COVID-19 receiving MV (n = 298; 28.2% on corticosteroids), the proportion with ≥1-point improvement in clinical status (alive, not receiving MV) at day 22 was 43.2% for sarilumab and 35.5% for placebo (risk difference, +7.5%; 95% confidence interval [CI], -7.4 to 21.3; P =.3261), a relative risk improvement of 21.7%. In post hoc analyses pooling phase 2 and 3 critical patients receiving MV, the hazard ratio for death for sarilumab vs placebo was 0.76 (95% CI, .51 to 1.13) overall and 0.49 (95% CI, .25 to .94) in patients receiving corticosteroids at baseline.
conclusionsThis study did not establish the efficacy of sarilumab in hospitalized patients with severe/critical COVID-19. Post hoc analyses were consistent with other studies that found a benefit of sarilumab in patients receiving corticosteroids. CLINICAL TRIALS REGISTRATION: NCT04315298.
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Registered trials
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.