Evidence map›Paper›PMID 38157348›Full record

Trial reportPloS one2023

Anakinra or tocilizumab in patients admitted to hospital with severe covid-19 at high risk of deterioration (IMMCoVA): A randomized, controlled, open-label trial.

Jonas Sundén-Cullberg, Puran Chen, Henrike Häbel, Paul Skorup, Helena Janols, Johan Rasmuson, Katarina Niward, Åse Östholm Balkhed, Katerina Chatzidionysiou, Hilmir Asgeirsson and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04412291 (A Multi-center, Randomized, Open-label Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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.

NCT04412291 phase2unknown statusnot on this map

A Multi-center, Randomized, Open-label Study in Patients With COVID-19 and Respiratory Distress Not Requiring Mechanical Ventilation, to Compare Standard-of-care With Anakinra and Tocilizumab Treatment The Immunomodulation-CoV Assessment (ImmCoVA) Study

TypeinterventionalSponsorKarolinska University HospitalRan2020 to 2021Enrolled120ConditionsCovid-19ArmsAnakinra Prefilled Syringe, Tocilizumab Prefilled Syringe, Standard-of-care treatment
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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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

23 authors.

Jonas Sundén-CullbergDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.ORCID 0000-0002-8189-4960
Puran ChenCenter for Infectious Medicine, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
Henrike HäbelDivision of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
Paul SkorupDepartment of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden.
Helena JanolsDepartment of Medical Sciences, Section of Infectious Diseases, Uppsala University, Uppsala, Sweden.
Johan RasmusonInfection and Immunology, Department of Clinical Microbiology, Umeå University, Umeå, Sweden.
Katarina NiwardDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Åse Östholm BalkhedDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Katerina ChatzidionysiouRheumatology Division, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Hilmir AsgeirssonDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.ORCID 0000-0003-3869-8021
Ola BlennowDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Åsa ParkeDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Anna-Karin SvenssonDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Jagadeeswara Rao MuvvaCenter for Infectious Medicine, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
Hans-Gustav LjunggrenCenter for Infectious Medicine, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
Karolinska KI/K COVID-19 Treatment Working Group
Anna-Carin HorneTheme of Children's and Women's Health, Karolinska University Hospital, Stockholm, Sweden.
Ulrika ÅdénDepartment of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Jan-Inge HenterChildhood Cancer Research Unit, Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.
Anders SönnerborgDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Jan VesterbackaDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Piotr NowakDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Jon LampaRheumatology Division, Department of Medicine Solna, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnakinra and tocilizumab are used for severe Covid-19, but only one previous randomized controlled trial (RCT) has studied both. We performed a multi-center RCT comparing anakinra or tocilizumab versus usual care (UC) for adults at high risk of deterioration.

methodsThe study was conducted June 2020 to March 2021. Eligibility required ≥ 5 liters/minute of Oxygen to maintain peripheral oxygen saturation at ≥ 93%, CRP > 70 mg/L, ferritin > 500 μg/L and at least two points where one point was awarded for lymphocytes < 1x 109/L; D-dimer ≥ 0.5 mg/L and; lactate dehydrogenase ≥ 8 microkatal/L. Patients were randomly assigned 1:1:1 to receive either a single dose of tocilizumab (8 mg/kg) or anakinra 100 mg IV QID for seven days or UC alone. The primary outcome was time to recovery.

resultsRecruitment was ended prematurely when tocilizumab became part of usual care. Out of a planned 195 patients, 77 had been randomized, 27 to UC, 28 to anakinra and 22 to tocilizumab. Median time to recovery was 15, 15 and 11 days. Rate ratio for recovery for UC vs anakinra was 0.91, 0.47 to 1.78, 95% [CI], p = 0.8 and for UC vs tocilizumab 1.13, 0.55 to 2.30; p = 0.7. There were non-significant trends favoring tocilizumab (and to limited degree anakinra) vs UC for some secondary outcomes. Safety profiles did not differ significantly.

conclusionPremature closure of trial precludes firm conclusions. Anakinra or tocilizumab did not significantly shorten time to clinical recovery compared to usual care. (IMMCoVA, NCT04412291, EudraCT: 2020-00174824).

Indexed as

COVID-19AdultAntibodies, Monoclonal, HumanizedCOVID-19 Drug TreatmentHospitalsHumansInterleukin 1 Receptor Antagonist ProteinSARS-CoV-2Treatment OutcomeAntibodies, Monoclonal, HumanizedInterleukin 1 Receptor Antagonist Proteintocilizumab

Identifiers

PMID38157348
PMCPMC10756513

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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.