Uvavanyo olutsha lweklinikhi kwizigulana ezine-Critical COVID-19 Pneumonia

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I-CalciMedica Inc., inkampani ye-CRAC (i-calcium release-activated activated) ye-channel ye-channel, namhlanje ibhengeze ukuqaliswa kwe-CARDEA-Plus, iSigaba se-2b solingo lwekliniki oluqhutywa e-United States naseKhanada, enokuthi isebenze njengesikhokelo kwiSigaba sayo. Inkqubo yophuhliso emi-3 ye-Auxora™ kwizigulana ezinenyumoniya ye-COVID-19.

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Ulingo lwenzelwe ukuqokelela idatha eyongezelelweyo yokhuseleko lwesigulane kunye ne-Auxora, ukuvavanya ukhuseleko kunye nokusebenza kwe-Auxora ngokudibanisa ne-tocilizumab kunye ne-corticosteroids, kunye nokuvavanya ukhuseleko kunye nokusebenza kakuhle kweentsuku ezintathu ngokubhekiselele kwi-dosing. Inkampani isandula ingxelo yedatha ephezulu kulingo lwayo lweSigaba sesi-2 se-CARDEA esixhasa izifundo ezongezelelweyo kwesi sigulana. 

I-CARDEA-Plus iya kubhalisa izigulana ze-COVID-19 zenyumoniya ezinomlinganiselo we-PaO2/FiO2 (P/F) ongu-≤200 ezifuna i-high-flow nasal cannula (HFNC) okanye i-nonvasive ventilation (NIV). Izigulane ziya kufumana i-2.0 mg / kg i-dose yokuqala ye-Auxora elandelwa yi-1.6 mg / kg kwiiyure ze-24, kunye ne-1.6 mg / kg kwiiyure ze-48. Ezo zigulana ezinomlinganiselo we-P/F we-≤100 okanye ekungeneni komoya ngoomatshini kwiiyure ezingama-48 ziya kufaneleka ukuba zithathwe ngokungenamkhethe ukufumana nokuba ziidosi ezintathu ze-Auxora okanye iidosi ezintathu ze-placebo. Zonke izigulana ziya kufumana umgangatho wokhathalelo olunokubandakanya ukusetyenziswa kwe-corticosteroids kunye/okanye i-tocilizumab.

"Ngaphandle kwamazinga okugonya i-COVID-19, inani eliphezulu lokulaliswa esibhedlele kunye nokufa kuseyingxaki enkulu," utshilo uSudarshan Hebbar, MD, iGosa eliyiNtloko lezoNyango laseCalciMedica. Ngelixa i-tocilizumab sele isetyenziswa kakhulu kwizigulana ezilaliswe esibhedlele nge-COVID-19, kusekho imfuneko yokuphucula iziphumo zesigulana. Sikholelwa ukuba i-Auxora inendlela eyodwa yokusebenza kunye nepropathi ye-pharmacokinetic enokubonelela ngoncedo lwezonyango kwizigulana ezinenyumoniya ye-COVID-19. ”

“Ukuqaliswa kolu phononongo, olukwavumela ulawulo lwe-Auxora ene-tocilizumab kunye ne-corticosteroids kwizigulana ezinenyumoniya ye-COVID-19, sisiganeko esibalulekileyo kwiNkampani yethu,” utshilo uRachel Leheny, Ph.D., iGosa eliyiNtloko yeSigqeba saseCalciMedica. . “Okubalulekileyo, iziphumo zolu phononongo, eziza kulandelwa ziingxoxo ne-FDA, ziya kwazisa ukuyilwa kovavanyo lwezonyango olunokubakho kwiSigaba sesi-3 ekupheleni kwalo nyaka. Sifumene uthakazelelo olubanzi kunye nenkxaso evela kwiindawo zabaphandi kolu phononongo kwaye silindele ukubhaliswa ngokukhawuleza. ”

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Umhleli oyintloko we-eTurboNew nguLinda Hohnholz. Uzinze kwi-eTN HQ e-Honolulu, eHawaii.

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