Evidence map›Paper›PMID 36104613›Full record

Trial reportInfection2023

DFV890: a new oral NLRP3 inhibitor-tested in an early phase 2a randomised clinical trial in patients with COVID-19 pneumonia and impaired respiratory function.

Ildiko Madurka, Alexander Vishnevsky, Joan B Soriano, Stephanus J Gans, Danilo Joel Salazar Ore, Adrian Rendon, Charlotte S Ulrik, Sushma Bhatnagar, Srikanth Krishnamurthy, Kirsten Mc Harry and 9 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Infection, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04382053 (Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function), which is not on this map. Cited by 48 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 2% 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.

NCT04382053 phase2completednot on this map

Phase 2, Randomized, Controlled, Open Label Multi-center Study to Assess Efficacy and Safety of DFV890 for the Treatment of SARS-CoV-2 Infected Patients With COVID-19 Pneumonia and Impaired Respiratory Function

TypeinterventionalSponsorNovartis PharmaceuticalsRan2020 to 2020Enrolled143ConditionsCOVID-19 Pneumonia, Impaired Respiratory FunctionArmsDFV890, Standard of Care (SoC)
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  5. Structure-Activity Relationship for Inflammasome Inhibition by Thiomuscimol.International journal of molecular sciences · 2026
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  10. "Bridging the clinical, molecular and genetic perspectives on myocarditis in post-COVID-19 era".International journal of cardiology. Cardiovascular risk and prevention · 2026
    Review
  11. Targeting PANoptosis in atherosclerosis: bridging cell death mechanisms and therapy.Apoptosis : an international journal on programmed cell death · 2026
    Review
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  14. Targeting PANoptosis: a promising therapeutic strategy for ALI/ARDS.Apoptosis : an international journal on programmed cell death · 2025
    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

19 authors at 12 institutions in 11 countries.

Ildiko MadurkaOrszagos Koranyi TBC es Pulmonologiai Intezet, Budapest, Hungary. pindurkamadurka@gmail.com.ORCID http://orcid.org/0000-0002-7083-0638
Alexander VishnevskySt Petersburg State Institution of Healthcare, Pokrovskaya City Hospital, St Petersburg, Russia.
Joan B SorianoHospital Universitario de la Princesa-UAM, Madrid, Spain.
Stephanus J GansZiekenhuis St. Jansdal, Harderwijk, Netherlands.
Danilo Joel Salazar OreHospital Nacional Cayetano Heredia, San Martin de Porres, Peru.
Adrian RendonHospital Universitario Dr José Eleuterio Gonzalez, CIPTIR, Monterrey, Mexico.
Charlotte S UlrikCopenhagen University Hospital-Hvidovre, Hvidovre, Denmark.
Sushma BhatnagarDepartment of Neurology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.
Srikanth KrishnamurthyHindusthan Hospital, Coimbatore, India.
Kirsten Mc HarryEden Task, George, South Africa.
Tobias WelteMedizinische Hochschule Hannover, Hannover, Germany.
Alberto A FernandezSanatorio Modelo de Quilmes, Buenos Aires, Argentina.
Beata MehesNovartis Pharma AG, Basel, Switzerland.
Karin MeiserNovartis Pharma AG, Basel, Switzerland.
Ewa GatlikNovartis Pharma AG, Basel, Switzerland.
Ulrike SommerNovartis Pharma AG, Basel, Switzerland.
Guido JungeNovartis Pharma AG, Basel, Switzerland.
Ederlon RezendeIntensive Care Unit, Hospital do Servidor Público Estadual Francisco Morato de Oliveira, São Paulo, Brazil.
Study group
Novartis (Switzerland) · CHAll India Institute of Medical Sciences · INHindustan Institute of Technology and Science · INHospital Nacional Cayetano Heredia · PEHospital Universitario de La Princesa · ESHospital Universitario Dr José Eleuterio Gonzalez · MXMedizinische Hochschule Hannover · DEOrszágos Korányi Tbc és Pulmonológiai Intézet · HUSt. Petersburg State Medical Academy "City Hospital No. 26" · RUTask Applied Science · ZAHvidovre Hospital · DKHospital do Servidor Público Estadual · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCoronavirus-associated acute respiratory distress syndrome (CARDS) has limited effective therapy to date. NLRP3 inflammasome activation induced by SARS-CoV-2 in COVID-19 contributes to cytokine storm.

methodsThis randomised, multinational study enrolled hospitalised patients (18-80 years) with COVID-19-associated pneumonia and impaired respiratory function. Eligible patients were randomised (1:1) via Interactive Response Technology to DFV890 + standard-of-care (SoC) or SoC alone for 14 days. Primary endpoint was APACHE II score at Day 14 or on day-of-discharge (whichever-came-first) with worst-case imputation for death. Other key assessments included clinical status, CRP levels, SARS-CoV-2 detection, other inflammatory markers, in-hospital outcomes, and safety.

findingsBetween May 27, 2020 and December 24, 2020, 143 patients (31 clinical sites, 12 countries) were randomly assigned to DFV890 + SoC (n = 71) or SoC alone (n = 72). Primary endpoint to establish clinical efficacy of DFV890 vs. SoC, based on combined APACHE II score, was not met; LSM (SE), 8·7 (1.06) vs. 8·6 (1.05); p = 0.467. More patients treated with DFV890 vs. SoC showed ≥ 1-level improvement in clinical status (84.3% vs. 73.6% at Day 14), earlier clearance of SARS-CoV-2 (76.4% vs. 57.4% at Day 7), and mechanical ventilation-free survival (85.7% vs. 80.6% through Day 28), and there were fewer fatal events in DFV890 group (8.6% vs. 11.1% through Day 28). DFV890 was well tolerated with no unexpected safety signals.

interpretationDFV890 did not meet statistical significance for superiority vs. SoC in primary endpoint of combined APACHE II score at Day 14. However, early SARS-CoV-2 clearance, improved clinical status and in-hospital outcomes, and fewer fatal events occurred with DFV890 vs. SoC, and it may be considered as a protective therapy for CARDS.

trial registrationClinicalTrials.gov, NCT04382053.

Indexed as

COVID-19Respiratory Distress SyndromeRespiratory InsufficiencyHumansNLR Family, Pyrin Domain-Containing 3 ProteinSARS-CoV-2NLR Family, Pyrin Domain-Containing 3 ProteinCoronavirus-associated acute respiratory distress syndromeDFV890NLRP3 inhibitorsRandomised controlled trialSARS-CoV-2

Identifiers

PMID36104613
PMCPMC9473473
OpenAlexW4295706186

What Socratic holds

Textmetadata
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 Socratic graph.