Evidence map›Paper›PMID 36936403›Full record

ArticleEClinicalMedicine2023

Sarilumab plus standard of care

Ilaria Mastrorosa, Roberta Gagliardini, Francesco Vladimiro Segala, Annalisa Mondi, Patrizia Lorenzini, Carlotta Cerva, Eleonora Taddei, Francesca Bai, Alessandra Vergori, Negri Marcantonio and 28 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 24% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

38 authors at 5 institutions in 1 country.

Ilaria MastrorosaNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Roberta GagliardiniNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Francesco Vladimiro SegalaFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Annalisa MondiNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Patrizia LorenziniNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Carlotta CervaNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Eleonora TaddeiFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Francesca BaiASST Santi Paolo e Carlo, University of Milan, Italy.
Alessandra VergoriNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Negri MarcantonioFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Carmela PinnettiNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Stefania CicaliniNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Rita MurriFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Valentina MazzottaNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Marta CamiciNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Silvia MostiNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Teresa BiniASST Santi Paolo e Carlo, University of Milan, Italy.
Gaetano MaffongelliNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Alessia BeccaceceNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Eugenia MilozziNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Marco IannettaUniversity of Rome Tor Vergata, Rome, Italy.
Silvia LamonicaFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Marisa FustoNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Maria Maddalena PlazziNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Sandrine OttouNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Miriam LichtnerSapienza University of Rome, Polo Pontino, Latina, Italy.
Massimo FantoniFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Massimo AndreoniUniversity of Rome Tor Vergata, Rome, Italy.
Loredana SarmatiUniversity of Rome Tor Vergata, Rome, Italy.
Roberto CaudaFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Enrico GirardiNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Emanuele NicastriNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Antonella D'Arminio MonforteASST Santi Paolo e Carlo, University of Milan, Italy.
Fabrizio PalmieriNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Antonella CingolaniFondazione Policlinico A. Gemelli, Catholic University of the Sacred Heart, Rome, Italy.
Francesco VaiaNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
Andrea AntinoriNational Institute for Infectious Diseases, Lazzaro Spallanzani IRCCS, Rome, Italy.
ESCAPE study group
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Rome Tor Vergata · ITUniversity of Milan · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Among interleukin-6 inhibitors suggested for use in COVID-19, there are few robust evidences for the efficacy of sarilumab. Herein, we evaluated the efficacy and safety of sarilumab in severe COVID-19. Methods: In this phase 3, open-labeled, randomized clinical trial, conducted at 5 Italian hospitals, adults with severe COVID-19 pneumonia (excluding mechanically ventilated) were randomized 2:1 to receive intravenous sarilumab (400 mg, repeatable after 12 h) Findings: Between May 2020 and May 2021, 191 patients were assessed for eligibility, of whom, excluding nine dropouts, 176 were assigned to arm A (121) and B (55). At day 30, no significant differences in the primary endpoint were found (88% [95% CI 81-94] in arm A Interpretation: The efficacy of sarilumab in severe COVID-19 was not demonstrated both in the overall and in the stratified for severity analysis population. Exploratory analyses suggested that subsets of patients with lower CRP values or lower lymphocyte counts might have had benefit with sarilumab treatment, but this finding would require replication in other studies. The relatively low rate of concomitant corticosteroid use, could partially explain our results. Funding: This study was supported by INMI "Lazzaro Spallanzani" Ricerca Corrente Linea 1 on emerging and reemerging infections, funded by Italian Ministry of Health.

Indexed as

Interleukin-6 receptor inhibitorsRandomized clinical trialSarilumabSARS-CoV-2 infectionSevere COVID-19 pneumonia

Identifiers

PMID36936403
PMCPMC9999914
OpenAlexW4323866415

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.