Ukuhlolwa Okusha Komtholampilo Ezigulini Ezine-Critical COVID-19 Pneumonia

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I-CalciMedica Inc., inkampani yesiteshi se-CRAC (calcium release-activated activated calcium), namuhla imemezele ukuqaliswa kwe-CARDEA-Plus, isivivinyo somtholampilo seSigaba 2b esiqhutshwa e-United States naseCanada, esingase sibe phambili esiGabeni saso. Uhlelo olu-3 lokuthuthukisa lwe-Auxora™ ezigulini ezinenyumoniya ye-COVID-19 ebalulekile.

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Ukuhlolwa kuklanyelwe ukuqoqa idatha eyengeziwe yokuphepha kwesiguli nge-Auxora, ukuhlola ukuphepha nokusebenza kwe-Auxora ngokuhambisana nakho kokubili i-tocilizumab ne-corticosteroids, nokuhlola ukuphepha nokusebenza ngempumelelo kwezinsuku ezintathu uma ziqhathaniswa nesithupha zomthamo. Inkampani isanda kubika idatha ephezulu evela ocwaningweni lwayo lweSigaba 2 se-CARDEA esekela izifundo ezengeziwe kulesi sibalo seziguli. 

I-CARDEA-Plus izobhalisa iziguli ezinenyumoniya ze-COVID-19 ezinesilinganiso se-PaO2/FiO2 (P/F) esingu-≤200 ezidinga i-high-flow nasal cannula (HFNC) noma i-noninvasive ventilation (NIV). Iziguli zizothola umthamo wokuqala we-Auxora ongu-2.0 mg/kg olandelwa ngu-1.6 mg/kg emahoreni angama-24, kanye no-1.6 mg/kg emahoreni angama-48. Lezo ziguli ezinesilinganiso se-P/F esingu-≤100 noma ekungeniseni umoya ngomshini emahoreni angu-48 zizofaneleka ukuhlelwa ngokungahleliwe ukuze zithole imithamo emithathu ye-Auxora noma imithamo emithathu ye-placebo. Zonke iziguli zizothola ukunakekelwa okujwayelekile okungase kuhlanganise ukusetshenziswa kwe-corticosteroids kanye/noma i-tocilizumab.

"Naphezu kokwenyuka kwamazinga okugomela i-COVID-19, isibalo esiphezulu sokulaliswa kanye nokufa kwabantu sisadala inkinga enkulu," kusho uSudarshan Hebbar, MD, Isikhulu Esiphezulu Sezokwelapha saseCalciMedica. “Yize i-tocilizumab isisetshenziswa kabanzi ezigulini ezilaliswe esibhedlela ezine-COVID-19, kusaqhubeka kunesidingo sokuthuthukisa imiphumela yesiguli. Sikholelwa ukuthi i-Auxora inendlela ehlukile yokwenza kanye nezakhiwo ze-pharmacokinetic ezingahlinzeka ngenzuzo yomtholampilo ezigulini ezinenyumoniya ye-COVID-19 ebucayi. "

"Ukuqaliswa kwalolu cwaningo, oluphinde luvumele ukuphathwa kwe-Auxora ene-tocilizumab kanye ne-corticosteroids ezigulini ezinenyumoniya ebucayi ye-COVID-19, kuyingqophamlando eNkampanini yethu," kusho uRachel Leheny, Ph.D., Isikhulu Esiphezulu seCalciMedica. . “Okubalulekile, imiphumela yalolu cwaningo, ezolandelwa yizingxoxo ne-FDA, izokwazisa ukuklanywa kocwaningo lomtholampilo olungase lweSigaba sesi-3 ngasekupheleni kwalo nyaka. Sithole isasasa nokusekelwa okuvela kumasayithi abaphenyi kulolu cwaningo futhi silindele ukubhaliswa okusheshayo.”

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