Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.
Marius TrøseidJosé R ArribasLambert AssoumouAleksander Rygh HoltenJulien PoissyVida TerzićFulvia MazzaferriJesús Rodríguez BañoJoe EustaceMaya HitesMichael JoannidisJosé-Artur PaivaJean ReuterIsabel PüntmannThale D J H Patrick-BrownElin WesterheimKaterina Nezvalova-HenriksenLydie BeniguelTuva Børresdatter DahlMaude BouscambertMonika HalanovaZoltán PéterfiSotirios TsiodrasMichael RezekMatthias BrielSerhat ÜnalMartin SchlegelFlorence AderKarine LacombeCecilie Delphin AmdalSerge RodriguesKristian TonbyAlexandre GaudetLars HeggelundJoy MootienAsgeir JohannessenJannicke Horjen MøllerBeatriz Diaz PollanAnders Aune TveitaAnders Benjamin KildalJean-Christophe RichardOlav DalgardVictoria Charlotte SimensenAliou BaldéLucie de GastinesMarta Del ÁlamoBurç AydinFridtjof Lund-JohansenMary-Anne TrabaudAlpha DialloBente HalvorsenJohn-Arne RøttingenEvelina TacconelliYazdan YazdanpanahInge C OlsenDominique Costagliolanull nullPublished in: Critical care (London, England) (2023)
This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu ( 2022-500385-99-00 ).