Kev sim tshuaj tshiab tshiab hauv cov neeg mob uas muaj tus kab mob COVID-19 tseem ceeb heev

Qhov kev sim no yog tsim los sau cov ntaub ntawv kev nyab xeeb ntxiv rau tus neeg mob nrog Auxora, ntsuas kev nyab xeeb thiab kev ua tau zoo ntawm Auxora ua ke nrog ob qho tib si tocilizumab thiab corticosteroids, thiab ntsuas kev nyab xeeb thiab kev ua tau zoo ntawm peb piv rau rau hnub ntawm kev noj tshuaj. Lub Tuam Txhab tsis ntev los no tau tshaj tawm cov ntaub ntawv saum toj kawg nkaus los ntawm nws qhov kev sim CARDEA Phase 2 uas txhawb nqa kev kawm ntxiv hauv cov neeg mob no. 

CARDEA-Plus yuav tso npe rau COVID-19 cov neeg mob ntsws ntsws nrog PaO2/FiO2 (P/F) piv ntawm ≤200 uas yuav tsum tau muaj qhov ntswg qhov ntswg (HFNC) lossis tsis muaj qhov cua (NIV). Cov neeg mob yuav tau txais 2.0 mg / kg thawj koob tshuaj Auxora tom qab 1.6 mg / kg ntawm 24 teev, thiab 1.6 mg / kg ntawm 48 teev. Cov neeg mob uas muaj qhov sib piv P / F ntawm ≤100 lossis ntawm cov tshuab ua pa thaum 48 teev yuav tsim nyog tau txais randomized kom tau txais peb koob tshuaj Auxora lossis peb koob tshuaj placebo. Txhua tus neeg mob yuav tau txais cov qauv kev saib xyuas uas yuav suav nrog kev siv corticosteroids thiab / lossis tocilizumab.

Sudarshan Hebbar, MD, Tus Thawj Saib Xyuas Kev Kho Mob ntawm CalciMedica tau hais tias "Txawm hais tias muaj kev txhaj tshuaj tiv thaiv ntau ntxiv rau COVID-19, cov tsev kho mob ntau thiab cov neeg tuag tseem ua rau muaj teeb meem loj," "Thaum tocilizumab tau dhau los siv dav hauv cov neeg mob hauv tsev kho mob nrog COVID-19, tseem muaj qhov xav tau los txhim kho cov txiaj ntsig ntawm tus neeg mob. Peb ntseeg tias Auxora muaj cov txheej txheem tshwj xeeb ntawm kev ua haujlwm thiab cov tshuaj pharmacokinetic uas tuaj yeem muab cov txiaj ntsig kho mob rau cov neeg mob uas muaj mob hnyav rau COVID-19. "

"Kev pib ntawm txoj kev tshawb fawb no, uas tseem tso cai rau kev tswj hwm ntawm Auxora nrog tocilizumab thiab corticosteroids hauv cov neeg mob uas muaj mob hnyav rau COVID-19 mob ntsws, yog lub sijhawm tseem ceeb rau peb lub tuam txhab," Rachel Leheny, Ph.D., Tus Thawj Saib Xyuas Haujlwm ntawm CalciMedica. . "Qhov tseem ceeb, cov txiaj ntsig ntawm txoj kev tshawb fawb no, yuav tsum tau ua raws los ntawm kev sib tham nrog FDA, yuav qhia txog kev tsim lub peev xwm ntawm Phase 3 kev sim tshuaj tom qab xyoo no. Peb tau txais kev txaus siab thiab kev txhawb nqa los ntawm cov chaw tshawb nrhiav rau txoj kev tshawb fawb no thiab cia siab tias yuav muaj kev tso npe sai. "

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