Evidence map›Paper›PMID 33631066›Full record

Trial reportThe New England journal of medicine2021

Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia.

Ivan O Rosas, Norbert Bräu, Michael Waters, Ronaldo C Go, Bradley D Hunter, Sanjay Bhagani, Daniel Skiest, Mariam S Aziz, Nichola Cooper, Ivor S Douglas and 13 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04320615 (A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia), which is not on this map. Cited by 654 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
654citing papers in PubMed, 8 pooled it
65.0field-weighted citation impact, top 1% 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.

NCT04320615 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2020Enrolled452ConditionsCOVID-19 PneumoniaArmsTocilizumab (TCZ), Placebo
3 · Its place in the literature

Who cites it

654 citing papers in PubMed, 8 syntheses or guidelines pooled it, 1,083 citations in OpenAlex.

  1. Pooled it
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594 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 1 institution in 1 country.

Ivan O RosasFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Norbert BräuFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Michael WatersFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Ronaldo C GoFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Bradley D HunterFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Sanjay BhaganiFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Daniel SkiestFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Mariam S AzizFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Nichola CooperFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Ivor S DouglasFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).ORCID 0000-0002-4541-1431
Sinisa SavicFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).ORCID 0000-0001-7910-0554
Taryn YoungsteinFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Lorenzo Del SorboFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Antonio Cubillo GracianFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
David J De La ZerdaFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Andrew UstianowskiFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Min BaoFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Sophie DimonacoFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Emily GrahamFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Balpreet MatharuFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Helen SpotswoodFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Larry TsaiFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Atul MalhotraFrom Baylor College of Medicine, Houston (I.O.R.); James J. Peters Veterans Affairs Medical Center, Bronx, and Icahn School of Medicine at Mount Sinai, New York - both in New York (N.B.); eStudy Site, Chula Vista (M.W.), Genentech, South San Francisco (M.B., L.T.), and the University of California, San Diego, La Jolla (A.M.) - all in California; Hackensack Meridian School of Medicine and Hacksensack University Medical Center, Hackensack, NJ (R.C.G.); Intermountain Healthcare, Salt Lake City (B.D.H.); Royal Free Hospital (S.B.) and Imperial College London (N.C., T.Y.), London, Leeds Teaching Hospitals NHS Trust and National Institute for Health Research-Leeds Biomedical Research Centre, Leeds (S.S.), North Manchester General Hospital, Manchester (A.U.), and Roche Products, Welwyn Garden City (S.D., E.G., B.M., H.S.) - all in the United Kingdom; the University of Massachusetts Medical School-Baystate, Springfield (D.S.); Rush University Medical Center, Chicago (M.S.A.); Denver Health Medical Center, Denver (I.S.D.), and the University of Colorado, Anschutz School of Medicine, Aurora (I.S.D.); University Health Network, Toronto (L.D.S.); Hospital Universitario HM Sanchinarro, Centro Integral, Oncológico Clara Campal and Departamento de Ciencias Médicas Clínicas, Facultad de Medicina, Universidad CEU San Pablo, Madrid (A.C.G.); and the University of Miami Miller School of Medicine, Miami (D.J.D.L.Z.).
Hackensack Meridian Health · US

Funding

Is Obstructive Sleep Apnea Important in the Development of Alzheimer's DiseaseR01AG063925 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL · 2020 to 2024
$3.7M
Single Motor Unit Genioglossus Recordings to Understand Sleep Apnea PathogenesisR01HL085188 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL · 2008 to 2018
$3.5M
Underlying mechanisms of obesity-induced obstructive sleep apneaR01HL148436 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Atul Malhotra · 2020 to 2026
$3.4M
Training in the Next Generation in Respiratory ScienceT32HL134632 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL, POWELL, FRANK L. · 2017 to 2021
$2.1M
Assessment of Upper Airway Mechanics Using Newer Electromyographic TechniquesK24HL132105 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL · 2016 to 2020
$611k
NHLBI NIH HHS K24 HL132105NHLBI NIH HHS R01 HL085188NHLBI NIH HHS R01 HL148436NHLBI NIH HHS T32 HL134632NIA NIH HHS R01 AG063925U.S. Department of Health and Human Services HHSO100201800036C
6 · The paper itself

Abstract

backgroundCoronavirus disease 2019 (Covid-19) is associated with immune dysregulation and hyperinflammation, including elevated interleukin-6 levels. The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia in case reports and retrospective observational cohort studies. Data are needed from randomized, placebo-controlled trials.

methodsIn this phase 3 trial, we randomly assigned patients who were hospitalized with severe Covid-19 pneumonia in a 2:1 ratio receive a single intravenous infusion of tocilizumab (at a dose of 8 mg per kilogram of body weight) or placebo. Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose. The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 (discharged or ready for discharge) to 7 (death) in the modified intention-to-treat population, which included all the patients who had received at least one dose of tocilizumab or placebo.

resultsOf the 452 patients who underwent randomization, 438 (294 in the tocilizumab group and 144 in the placebo group) were included in the primary and secondary analyses. The median value for clinical status on the ordinal scale at day 28 was 1.0 (95% confidence interval [CI], 1.0 to 1.0) in the tocilizumab group and 2.0 (non-ICU hospitalization without supplemental oxygen) (95% CI, 1.0 to 4.0) in the placebo group (between-group difference, -1.0; 95% CI, -2.5 to 0; P = 0.31 by the van Elteren test). In the safety population, serious adverse events occurred in 103 of 295 patients (34.9%) in the tocilizumab group and in 55 of 143 patients (38.5%) in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group (weighted difference, 0.3 percentage points; 95% CI, -7.6 to 8.2; nominal P = 0.94).

conclusionsIn this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days. (Funded by F. Hoffmann-La Roche and the Department of Health and Human Services; COVACTA ClinicalTrials.gov number, NCT04320615.).

Indexed as

COVID-19 Drug TreatmentAdultAgedAntibodies, Monoclonal, HumanizedCOVID-19Double-Blind MethodFemaleHospitalizationHospital MortalityHumansInfusions, IntravenousIntensive Care UnitsMaleMiddle AgedReceptors, Interleukin-6Respiration, ArtificialAntibodies, Monoclonal, HumanizedReceptors, Interleukin-6tocilizumab

Identifiers

PMID33631066
PMCPMC7953459
OpenAlexW3129869280

What OpenQuestion holds

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Read underepoch 390

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.