biostudies-literatureUnknown51(3)Madurka INovartis Pharma AG<h4>Background</h4>Coronavirus-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.<h4>Methods</h4>This 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.<hInfection641-654https://www.ebi.ac.uk/biostudies/studies/S-EPMC9473473biostudies-literatureDFV890: a new oral NLRP3 inhibitor-tested in an early phase 2a randomised clinical trial in patients with COVID-19 pneumonia and impaired respiratory function.PMC9473473Zerega NBhan SGoebeler MEDatta AKurguzova DPabel SIharos DViladomiu ASMalacize VQBauernfeind SLazarenko IVKotov MESag SFlores EMZUlrik CSEgorova EAJunge GOrihuela BGPerez ROFOre DJSWelte TAlferov SPMarcos MCBachman MEsze TOlzik IFrey APedersen KBHBlinova EVRodriguez BNLMartynenko TIHejja MMoncivais BSKharlamova SSchulze PMc Harry KHanses FMeiser KSementsov KVBrigante JAOsornio JSPink IScharf NKrishnamurthy SGounder SKMHakansson KBarbosa GRZeller JMedina MAJDel Pino RMGanova OSRadchenko ENToth KKKaneesan KWeismann DMcHarry KParaeva OSSerrano DRBagu AMStoll MRipfel SSoriano JBNalin SSaha AVishneva EMSayehli CMMohan AKist GRRudikh OVFernandes CCRendon AHinovker VVGatalsky KKCardozo CVaidyanathan VAgrawal AUnnithan MRJBelekhov GAFarronay MIMBoeve-Epping NKatagarov DNFilik HRepnikov IStadnik CMBGans SJGatlik EBhopale SLeisner UShearman NMehes BBoom LBustios ERMPandit AGeismann FVanDen Berg JWVishnevsky AMessnikov OJaoude CVGKlinker HSingh RMartynov AVAntonov VNKrylov AAPinzhina VNPanhuis EVishnevsky AYTiwari PTrufanov KVSoriano JGaygolnik TVIgnatova GLCosta MBLammens MBondareva YARatre BKRamos EAOrtiz ACMorozov EGarcia FBenfield TMadurka ISommer ULancee GPashkevich VVGarkavi DAStudy groupAbramov VGKiseleva MGrebneva IVLubnow MRezende EVig SSrikanth Ade Olivera EPVergara AMHupf JSmolyarchuk EAde Carvalho Rezende EAOrtega MLMVelayuthaswamy NRodionova OVFernandez AARagognete HGSrinivasan NAhmed NJBacci MRTidemandsen CVasileva EHitzenbichler FPerez DLCAmido FHBhatnagar SBhattacharjee AMaier LRamirez EJRTerskikh MMSnyman EFranco GIsakova APBudhraja AZykov VAKumar BfalseDFV890: a new oral NLRP3 inhibitor-tested in an early phase 2a randomised clinical trial in patients with COVID-19 pneumonia and impaired respiratory function.<h4>Background</h4>Coronavirus-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.<h4>Methods</h4>This 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.<h2023-01-01T00:00:00Z2023 Jun2026-06-18T07:00:44.471Z2024-12-03T16:19:55.011ZS-EPMC94734733610461310.1007/s15010-022-01904-w